Vascular DementiaPhase 3NCT03789760
The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) Capsule
A Phase 3 study testing SaiLuoTong capsule in people with Vascular Dementia, run by Shineway Pharmaceutical Co.,Ltd at 29 sites in China.
Trial summary
As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- SaiLuoTong capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 493 participants
- Where
- 29 sitesChina
- Study dates
- 10 Apr 2019to 19 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years≤Age≤75 years, female or male.
- With an education at more than (including) 6 years.
- Meet the diagnostic criteria for dementia in Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).
- Meet the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche etl'Enseignement en Neurosciences(NINDS-AIREN) Criteria of Probable Vascular Dementia (1993).
- MRI (magnetic resonance imaging) supports the presence of ischemic cerebrovascular disease, and meets NINDS-AIREN Imaging Criteria; the diameter of each infarct≤ 30mm(And the perivascular spaces and cerebral microbleeds were excluded).
- Modified Hachinski Ischemic (mHIS) Scale ≥ 4.
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- Hamilton depression scale (HAMD) ≤ 17.
- Patients with mild or moderate VaD: 10 ≤ MMSE ≤ 26 and 1 ≤ CDR ≤ 2.
- Willing to participate in this study and could sign the informed consent form by him/herself and lawful guardian prior to the study.
- The subjects must have a care giver who are cognitively normal (MMSE scores: illiteracy> 17 points, 1 - 6 years of education > 20 points, 7 years and above of education > 24 points). The care giver shall also be able to take care of the patient at least 4 days a week for more than 4 hours a day while he or she can accompany the subjects to attend each visit. During the trial, a new caregiver must have MMSE score and the results would be presented in forms of subjects in the attachment.
Who cannot join
- Patients with dementia caused by a brain disease other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, central nervous system demyelinative diseases, tumour, hydrocephalus, trauma, central nervous system infection, such as syphilis, AIDS and Creutzfeldt-Jakob disease);
- Patients with serious neurological impairment to finish the examination: hand hemiplegia, aphasia, and visual or hearing impairment.
- Laboratory anomalies: hemoglobin (Hb) level less than 80g/L , platelet count (Plt) level less than 50×109/L, activated partial thromboplastin time (APTT) exceeds 2.5 times the normal upper level, fibrinogen(FIB) level less than 0.5g/L, prothrombin time (PT) exceeds 2.5 times the normal upper level, Serum creatinine (Scr) exceeds 3 times the normal upper level, alanine aminotransferase (ALT) exceed 5 times the normal upper level , aspartate aminotransferase (AST) exceed 5 times the normal upper level, alkaline phosphates (ALP) exceed 5 times the normal upper level , γ-glutamyl transferase (γ-GT) exceed 5 times the normal upper level, total bilirubin (TBiL) exceeds 3 times the normal upper level.
- The subjects have nutritional and metabolic diseases and endocrine system diseases that cannot been controlled by therapy - thyroid diseases, parathyroid disease, vitamin or element deficiency.
- Patients with serious circulatory system diseases, respiratory system diseases, urinary system diseases, digestive system diseases, haemopoietic system diseases (such as unstable angina, uncontrollable asthma and active gastrorrhagia) and cancer.
- Serious mental disease (such as depression and schizophrenia) and epilepsy.
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- Gastrointestinal diseases that may affect the absorption, distribution, and metabolism of the investigational drug.
- Alcohol and drug abuse.
- Patients who have been given any drug that can affect the cognitive function (including Chinese herbal preparations containing any one of these: ginseng, ginkgo leaf, and saffron; Western medicines such as donepezil, karbalatine, rivastigmine, huperzine a, memantine and similar drugs, etc; Butylphthalide and other drugs with the same effect such as runeirergine, aniracetam, cytosporine, dihydroergine, nimodipine, etc) within one month before the start of this study and cannot be discontinued.
- Patients who are allergic to more than 2 drugs or any component of the SLT capsules.
- Pregnant or lactating women.
- Patients who have participated in other clinical studies within 3 months prior to this study.
- Cannot accept magnetic resonance imaging (MRI) examination.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Affiliated Hospital of Hebei University
Baoding, Hebei
Baogang Hospital
Baotou, Inner Mongolia, 014000
Xuan Wu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Xiyuan Hospital
Beijing, Beijing Municipality
The First Hospital of Changsha
Changsha, Hunan, 41000
Xiangya Boai Rehability Hospital
Changsha, Hunan
Changzhi People's Hospital
Changzhi, Shanxi, 046000
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000
Handan First Hospital
Handan, Hebei, 056000
The Fourth Hospital of Medical University
Harbin, Hei Longjiang
Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia
Jinzhong First People's Hospital
Jinzhong, Shanxi
Jiujiang University Clinical Medical College ▪ Jiujiang University Hospital
Jiujiang, Jiangxi, 332000
Hebei Central Hospital of petrochina
Langfang, Hebei, 065000
The Central Hospital of Lishui City
Lishui, Zhejiang, 323000
The First People's Hospital of Luoyang
Luoyang, Henan, 471000
Nanchang Hongdu Hospital of TCM
Nanchang, Jiangxi
The First affiliated Hospital of Nanyang Medical college
Nanyang, Henan, 473000
Nanyang Second People's Hospital
Nanyang, Henan, 473003
The Second people's Hospital of Neijiang
Neijiang, Sichuan
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Taizhou Hospital of Chinese Medicine
Taizhou, Jiangsu, 225300
Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300250
The Second Hospital of Xingjiang Medical University
Ürümqi, Xingjiang
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, 712000
Yueyang Second People's Hospital
Yueyang, Hunan, 414000
Yuncheng Central Hospital
Yuncheng, Shanxi
About this study
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel, and Multi-centre Study to Evaluate the Clinical Efficacy and Safety of SaiLuoTong (SLT) in the Treatment of Vascular Dementia
As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. So the study hypothesis is also that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to confirm the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.
Read the detailed description
Vascular dementia (VaD) is a clinical syndrome of acquired intellectual and functional impairment that results from cerebrovascular diseases. SaiLuoTong capsule is a traditional Chinese medicine compound; it is composed of ginseng extract (the main composition: ginseng total saponins), ginkgo biloba extract (the main composition: YinXingTong ester) and safflower extract (the main composition: the west safflower total glycosides). The function of SaiLuoTong capsule is Yiqi Huoxue and Huayu Tongluo in Chinese traditional medicine theory. Pharmacodynamics studies showed that SaiLuoTong capsule can significantly improve neurological symptoms caused by focal cerebral ischemia in animals, and learning and memory ability in animal models of VaD. The result of the phase II study showed that the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. Based on these previous evidences, the investigators conduct this study to further confirm the efficacy and safety of SaiLuoTong capsule in patients with mild to moderate VaD. This study is a phase III clinical trial of SaiLuoTong capsule for treatment of vascular dementia. The study is a 52-week, multicentre, randomized, double -blind, placebo-controlled study.
- Conditions
- Vascular Dementia
- Being tested
- SaiLuoTong capsule, placebo
- Keywords
- Vascular Dementia, cognitive
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaiLuoTong capsuleDrug
Also called The effects of SaiLuoTong capsule on VaD
500 subjects are randomly divided into two groups by 3:1. 375 subjects in the active group take two pills(120mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
placeboDrug
500 subjects are randomly divided into two groups by 3:1. 125 subjects in the control group take two pills(120mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
| Study group | Role | What they receive |
|---|---|---|
| active group | Experimental | take two pills (120 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water. Receives: Drug: SaiLuoTong capsule |
| control group | Placebo comparator | take two pills (120 mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
The VaDAS-cog comprises the Alzheimer's disease assessment scale(ADAS-cog) plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 52.
Measured: Change from baseline VaDAS-cog score at Week 52
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
The Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).
Measured: Change from baseline ADCS-CGIC score at Week 52
Secondary outcomes (22)
Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL)
To assess the daily living activity of the patients, including a subgroup in which there are 23 items to be checked and the total score is 78. A higher score represents a better daily living activity, vice versa. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean,SD) of precise scores at week 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline ADCS-ADL score at Week 26
Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL)
To assess the daily living activity of the patients, including a subgroup in which there are 23 items to be checked and the total score is 78. A higher score represents a better daily living activity, vice versa. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean,SD) of precise scores at week 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline ADCS-ADL score at Week 52
Mini-mental State Examination(MMSE)
The MMSE is a global test of cognitive function, for which the total score ranges from 0 to 30, with higher scores indicating lesser severity. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean, SD) of precise scores at screening (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline MMSE score at Week 26
Mini-mental State Examination(MMSE)
The MMSE is a global test of cognitive function, for which the total score ranges from 0 to 30, with higher scores indicating lesser severity. The score of each item is summed to compute a total score. The data in the table below is the statistical data (mean, SD) of precise scores at screening (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline MMSE score at Week 52
Clinical Dementia Rating(CDR Scale )
The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Talk to the patients or those who know well about the patients and assess the 6 functions (memory, orientation, judgment and problem-solving ability, social activities, household duties and hobbies as well as self-care ability) to obtain the scores and based on the predetermined principles the CDR score is calculated. The diagnostic criteria[68]: normal-CDR=0; suspected dementia-CDR=0.5, mild dementia-CDR=1; moderate dementia- CDR=2; and serious dementia-CDR=3. The data in the table below is the statistical data (mean, SD) of precise scores at baseline and weeks 26.
Measured: Change from baseline CDR Scale score at Week 26
Clinical Dementia Rating(CDR Scale )
The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage'). Talk to the patients or those who know well about the patients and assess the 6 functions (memory, orientation, judgment and problem-solving ability, social activities, household duties and hobbies as well as self-care ability) to obtain the scores and based on the predetermined principles the CDR score is calculated. The diagnostic criteria[68]: normal-CDR=0; suspected dementia-CDR=0.5, mild dementia-CDR=1; moderate dementia- CDR=2; and serious dementia-CDR=3. The data in the table below is the statistical data (mean, SD) of precise scores at baseline and weeks 52.
Measured: Change from baseline CDR Scale score at Week 52
Clinical Dementia Rating sum of boxes(CDR-sb)
CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment. CDR-sb is the algebraic sum of 6 functional domains with a range of 0(normal) - 18(severe dementia). The data in the table below is the statistical data (mean,SD) of precise scores at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline CDR-sb score at Week 26
Clinical Dementia Rating sum of boxes(CDR-sb)
CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment. CDR-sb is the algebraic sum of 6 functional domains with a range of 0(normal) - 18(severe dementia). The data in the table below is the statistical data (mean,SD) of precise scores at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline CDR-sb score at Week 52
Blood biomarker: Brain-derived neurotrophic factor(BDNF)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline BDNF at Week 26
Blood biomarker: Brain-derived neurotrophic factor(BDNF)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0(baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline BDNF at Week 52
Blood biomarker: Vascular endothelial growth factor(VEGF)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline VEGF at Week 26
Blood biomarker: Vascular endothelial growth factor(VEGF)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline VEGF at Week 52
Blood biomarker: Matrix metalloproteinase-9(MMP-9)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline MMP-9 at Week 26
Blood biomarker: Matrix metalloproteinase-9(MMP-9))
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline MMP-9 at Week 52
Blood biomarker: Interleukin-6(IL-6)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 26.
Measured: Change from baseline MMP-9 at Week 26
Blood biomarker: Interleukin-6(IL-6)
The data in the table below is the statistical data (mean,SD) of precise measurement at weeks 0 (baseline), while the statistical data of difference value compared to the score of baseline at weeks 52.
Measured: Change from baseline MMP-9 at Week 52
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 13.
Measured: Change from baseline VaDAS-cog score at week 13
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 26.
Measured: Change from baseline VaDAS-cog score at week 26
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
The VaDAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 39.
Measured: Change from baseline VaDAS-cog score at week 39
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).
Measured: Change from baseline ADCS-CGIC score at week 13
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).
Measured: Change from baseline ADCS-CGIC score at week 26
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).
Measured: Change from baseline ADCS-CGIC score at week 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start10 Apr 2019
- Primary completion12 Mar 2024
- Study completion19 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shineway Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianping Jia, Professor, Principal investigator, Xuan Wu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789760
- Sponsor's protocol ID
- SW003
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel, and Multi-centre Study to Evaluate the Clinical Efficacy and Safety of SaiLuoTong (SLT) in the Treatment of Vascular Dementia
- ClinicalTrials.gov ID
- NCT03789760
- Acronym / sponsor ID
- SW003
- Conditions
- Vascular Dementia
- Keywords
- Vascular Dementia, cognitive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Shineway Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 19 May 2024 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). According to the result of the phase II study, the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. So the study hypothesis is also that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to confirm the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.
Detailed description
Vascular dementia (VaD) is a clinical syndrome of acquired intellectual and functional impairment that results from cerebrovascular diseases. SaiLuoTong capsule is a traditional Chinese medicine compound; it is composed of ginseng extract (the main composition: ginseng total saponins), ginkgo biloba extract (the main composition: YinXingTong ester) and safflower extract (the main composition: the west safflower total glycosides). The function of SaiLuoTong capsule is Yiqi Huoxue and Huayu Tongluo in Chinese traditional medicine theory. Pharmacodynamics studies showed that SaiLuoTong capsule can significantly improve neurological symptoms caused by focal cerebral ischemia in animals, and learning and memory ability in animal models of VaD. The result of the phase II study showed that the efficacy of SaiLuoTong capsule in the treatment of patients with VaD was better than that of placebo group and no difference in safety. Based on these previous evidences, the investigators conduct this study to further confirm the efficacy and safety of SaiLuoTong capsule in patients with mild to moderate VaD. This study is a phase III clinical trial of SaiLuoTong capsule for treatment of vascular dementia. The study is a 52-week, multicentre, randomized, double -blind, placebo-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active group | Experimental | Drug: SaiLuoTong capsuletake two pills (120 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water. |
| control group | Placebo comparator | Drug: placebotake two pills (120 mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 40 years≤Age≤75 years, female or male.
- With an education at more than (including) 6 years.
- Meet the diagnostic criteria for dementia in Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).
- Meet the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche etl'Enseignement en Neurosciences(NINDS-AIREN) Criteria of Probable Vascular Dementia (1993).
- MRI (magnetic resonance imaging) supports the presence of ischemic cerebrovascular disease, and meets NINDS-AIREN Imaging Criteria; the diameter of each infarct≤ 30mm(And the perivascular spaces and cerebral microbleeds were excluded).
Key exclusion criteria (13 listed)
- Patients with dementia caused by a brain disease other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, central nervous system demyelinative diseases, tumour, hydrocephalus, trauma, central nervous system infection, such as syphilis, AIDS and Creutzfeldt-Jakob disease);
- Patients with serious neurological impairment to finish the examination: hand hemiplegia, aphasia, and visual or hearing impairment.
- Laboratory anomalies: hemoglobin (Hb) level less than 80g/L , platelet count (Plt) level less than 50×109/L, activated partial thromboplastin time (APTT) exceeds 2.5 times the normal upper level, fibrinogen(FIB) level less than 0.5g/L, prothrombin time (PT) exceeds 2.5 times the normal upper level, Serum creatinine (Scr) exceeds 3 times the normal upper level, alanine aminotransferase (ALT) exceed 5 times the normal upper level , aspartate aminotransferase (AST) exceed 5 times the normal upper level, alkaline phosphates (ALP) exceed 5 times the normal upper level , γ-glutamyl transferase (γ-GT) exceed 5 times the normal upper level, total bilirubin (TBiL) exceeds 3 times the normal upper level.
- The subjects have nutritional and metabolic diseases and endocrine system diseases that cannot been controlled by therapy - thyroid diseases, parathyroid disease, vitamin or element deficiency.
- Patients with serious circulatory system diseases, respiratory system diseases, urinary system diseases, digestive system diseases, haemopoietic system diseases (such as unstable angina, uncontrollable asthma and active gastrorrhagia) and cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaiLuoTong capsuleAlso: The effects of SaiLuoTong capsule on VaD500 subjects are randomly divided into two groups by 3:1. 375 subjects in the active group take two pills(120mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water. | Drug | active group |
| placebo500 subjects are randomly divided into two groups by 3:1. 125 subjects in the control group take two pills(120mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water. | Drug | control group |
Primary outcome
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
Time frame: Change from baseline VaDAS-cog score at Week 52
The VaDAS-cog comprises the Alzheimer's disease assessment scale(ADAS-cog) plus the Maze and Number Cancellation test to specifically assess executive function. The score of each item is summed to compute a total score. The range of the total score was from 0(no cognitive impairment) to 90(severe cognitive impairment). The data in the table below is the statistical data (mean,SD) of precise scores at screening and week 0 (baseline), while the statistical data of difference value compared to the score of Baseline at weeks 52.
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
Time frame: Change from baseline ADCS-CGIC score at Week 52
The Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC) involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change. In week 0 (baseline), the score was to judge the severity of the cognitive, 0(no evaluate),1(normal),2(slight intelligence obstacle),3(mide intelligence obstacle),4(moderate intelligence obstacle),5(significantly intelligence obstacle),6(severe intelligence obstacle),7(intelligent obstacle end-stage). In week 13,26,39,52, the score was to judge the change of the clinical global impression,1(improved significantly),2(improve),3(improve a little),4(no change),5(a little deteriorated),6(deteriorated),7(serious deterioration).
22 secondary outcomes
Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL)
Time frame: Change from baseline ADCS-ADL score at Week 26
Alzheimer's Disease Cooperative Study-activities of Daily Living(ADCS-ADL)
Time frame: Change from baseline ADCS-ADL score at Week 52
Mini-mental State Examination(MMSE)
Time frame: Change from baseline MMSE score at Week 26
Mini-mental State Examination(MMSE)
Time frame: Change from baseline MMSE score at Week 52
Clinical Dementia Rating(CDR Scale )
Time frame: Change from baseline CDR Scale score at Week 26
Clinical Dementia Rating(CDR Scale )
Time frame: Change from baseline CDR Scale score at Week 52
Clinical Dementia Rating sum of boxes(CDR-sb)
Time frame: Change from baseline CDR-sb score at Week 26
Clinical Dementia Rating sum of boxes(CDR-sb)
Time frame: Change from baseline CDR-sb score at Week 52
Blood biomarker: Brain-derived neurotrophic factor(BDNF)
Time frame: Change from baseline BDNF at Week 26
Blood biomarker: Brain-derived neurotrophic factor(BDNF)
Time frame: Change from baseline BDNF at Week 52
Blood biomarker: Vascular endothelial growth factor(VEGF)
Time frame: Change from baseline VEGF at Week 26
Blood biomarker: Vascular endothelial growth factor(VEGF)
Time frame: Change from baseline VEGF at Week 52
Blood biomarker: Matrix metalloproteinase-9(MMP-9)
Time frame: Change from baseline MMP-9 at Week 26
Blood biomarker: Matrix metalloproteinase-9(MMP-9))
Time frame: Change from baseline MMP-9 at Week 52
Blood biomarker: Interleukin-6(IL-6)
Time frame: Change from baseline MMP-9 at Week 26
Blood biomarker: Interleukin-6(IL-6)
Time frame: Change from baseline MMP-9 at Week 52
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
Time frame: Change from baseline VaDAS-cog score at week 13
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
Time frame: Change from baseline VaDAS-cog score at week 26
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog)
Time frame: Change from baseline VaDAS-cog score at week 39
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
Time frame: Change from baseline ADCS-CGIC score at week 13
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
Time frame: Change from baseline ADCS-CGIC score at week 26
Alzheimer's Disease Cooperative Study-clinical Global Impression of Change(ADCS-CGIC)
Time frame: Change from baseline ADCS-CGIC score at week 39
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianping Jia, Professor principal investigator
Xuan Wu Hospital of Capital Medical University
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SaiLuoTong capsule in people with Vascular Dementia, run by Shineway Pharmaceutical Co.,Ltd at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Dementia Assessment Scale-cognitive Subscale(VaDAS-cog) (time frame: Change from baseline VaDAS-cog score at Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.