Vascular Cognitive ImpairmentPhase 2/3NCT04301466
Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment
A Phase 2/3 study testing Qi Zhi Tong Luo capsule in people with Vascular Cognitive Impairment and Qi Zhi Tong Luo Capsule, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
Qi Zhi Tong Luo (QZTL) capsule, a traditional Chinese herbal medicine, which was used to treat stoke-related symptoms, include trouble speaking, paralysis and trouble walking. This study aimed to evaluate the efficacy and safety of QZTL capsule in the treatment of vascular cognitive impairment. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Vascular Cognitive Impairment, Qi Zhi Tong Luo Capsule, Randomized Controlled Trial
- What is being tested?
- Qi Zhi Tong Luo capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2014to 30 May 2018
- Phase
- Phase 2/3
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decline in cognitive function from a prior baseline and impairment in at least 1 cognitive domain, the domain of cognition including executive function(Trail Making Test-part A(Chinese version,150s)>98s)), memory function decline (Hopkins verbal learning test free recall(36 points) <18.5 points), language function decline (Boston naming test (Chinese version 30 items)<22 points), and visuo-spatial functions (Clock drawing test(10 points)<8.5 points) ;
- Evidence of cerebrovascular disease relies on structural magnetic resonance imaging (MRI) , history and clinical feature. The neuroimaging should include at least one of following: a) a single large vessel infarction which was sufficient to cause cognition decline; b) infarction at a single strategic place was sufficient to cause severe cognition decline( the thalamus, angular gyrus, and basal ganglia, including the caudate nucleus and globus pallidus); c) multiple lacunar infarctions (≥3) outside the brainstem, or 2 lacunar infarcts at key locations, a single lacunar focus with extensive white matter lesions(WMLs) ; d) extensive and integrated WMLs(Fazekas scale≥3 points) ; e) intracranial hemorrhage in key parts, or ≥2 intracranial hemorrhages; f) combination of above.
- There was a clear temporal relationship between a vascular event and onset of cognitive deficit, cognitive impairment should appear within 3 months after a stroke, or abrupt deterioration, or stepwise progression of deficits; or cognitive impairment may be related to vascular factors, the Hachinski Ischemia scale (HIS) score ≥7;
- And the patients must have adequate vision and hearing to participate in study assessments;
- Have a stable caregiver;
- Can read simple articles and write simple sentences;
- Informed consent, signed informed consent by legal guardian.
Who cannot join
- Evidence of other reasons caused cognitive impairment, like Alzheimer disease, frontotemporal dementia, Parkinson disease dementia, dementia with Lewy bodies, Huntington disease, etc;
- Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease, vitamin deficiency, or other diseases which can lead to cognitive impairment;
- Major depression (Hamilton depression rating scale [HAMD] ≥17) or other mental disorders ;
- History of drug or alcohol abuse in the past 6 month;
- History of epilepsy;
- Patients with myasthenia gravis;
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- Subject cannot complete related test due to severe neurologic deficits;
- Other uncontrolled chronic illnesses, like severe cardiovascular disease (severe arrhythmia, myocardial infarction within 3 months, severe heart failure(New York Heart Association Functional Classification III and IV,); uncontrolled hypertension, diabetes);
- Severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase was more than 1.5 times the upper limit of normal, or serum creatinine was more than the upper limit of normal);
- Concomitant use of the anticonvulsants, antipsychotics, cholinomimetic drugs, anticholinergic agents, anti-Parkinson drugs, cholinesterase inhibitors, memantine, nootropic drug, nimodipine, anticholinergic or anticholinergic antidepressant or anxiolytic and other cognition enhancers within 1 month;
- Severe asthma and chronic obstructive pulmonary disease;
- Patients with severe indigestion, gastrointestinal obstruction, gastric or duodenal ulcers;
- Patients with glaucoma;
- History of hypersensitivity to the treatment drugs;
- Participate in other clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
About this study
Official title: Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment: a Randomized, Double-blind, Placebo- Controlled, Multicentre Study
Qi Zhi Tong Luo (QZTL) capsule, a traditional Chinese herbal medicine, which was used to treat stoke-related symptoms, include trouble speaking, paralysis and trouble walking. This study aimed to evaluate the efficacy and safety of QZTL capsule in the treatment of vascular cognitive impairment. This study was designed as randomized, double-blind, parallel, placebo-controlled, multicentre trial. It consisted of a single-blind run-in period using placebo only (2 weeks) and a double-blind treatment phase after randomization (24 weeks), and follow-up 12 weeks after withdrawal.The primary efficacy variables included changes from baseline in the Clinical Dementia Rating scale-Sum Box (CDR-SB) and the Mini-mental State Examination (MMSE) after 24 weeks of treatment. The secondary efficacy measurements include the Clock Drawing Test (CDT), Hopkins Verbal Learning Test (HVLT) and Ability of Daily Living (ADL).
- Being tested
- Qi Zhi Tong Luo capsule, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi Zhi Tong Luo capsuleDrug
Patients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. QZTL capsule, a traditional Chinese medicine. Each capsule was weighted 0.5g.
PlacebosDrug
Patients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks.To preserve blinding, the placebo had an identical taste and appearance to the experimental drugs. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Qi Zhi Tong Luo group | Experimental | Patients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. Each capsule was weighted 0.5g. Qi Zhi Tong Luo capsule (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd. Receives: Drug: Qi Zhi Tong Luo capsule |
| Placebo group | Placebo comparator | Patients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Clinical Dementia Rating-Sum of the Boxes scale (CDR-SB) from baseline
CDR-SB is a standard for disease grading in clinical studies of dementia and is used for overall endpoint assessment in clinical trials. The CDR-SB scores from 0-18 points, and a higher score indicates higher impairment.
Measured: week 0, 12, 24,36
Changes of Mini-mental State Examination(MMSE from baseline
MMSE, 0-30 points, a lower score means severe global cognition impairment, which is used for overall endpoint assessment in clinical trials.
Measured: week 0, 12, 24,36
Secondary outcomes (3)
Changes of Hopkins Verbal Learning Test from baseline
0-48 points, higher score indicates better memory function
Measured: week 0, 12, 24,36
Changes of Clock drawing test from baseline
0-10 points, with higher scores indicating better visuo-spatial function
Measured: week 0, 12, 24,36
Changes of Ability of daily living scale from baseline
0-56 points, higher score means severe ability daily living function
Measured: week 0, 12, 24,36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start16 Jul 2014
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Cognitive ImpairmentStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Zhendong Pharmacy Co., Ltd
- Responsible party
- Principal investigator, Jinzhou Tian, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301466
- Sponsor's protocol ID
- B20020126
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment: a Randomized, Double-blind, Placebo- Controlled, Multicentre Study
- ClinicalTrials.gov ID
- NCT04301466
- Acronym / sponsor ID
- B20020126
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Shanxi Zhendong Pharmacy Co., Ltd
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 10 Mar 2020 (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.
Qi Zhi Tong Luo (QZTL) capsule, a traditional Chinese herbal medicine, which was used to treat stoke-related symptoms, include trouble speaking, paralysis and trouble walking. This study aimed to evaluate the efficacy and safety of QZTL capsule in the treatment of vascular cognitive impairment. This study was designed as randomized, double-blind, parallel, placebo-controlled, multicentre trial. It consisted of a single-blind run-in period using placebo only (2 weeks) and a double-blind treatment phase after randomization (24 weeks), and follow-up 12 weeks after withdrawal.The primary efficacy variables included changes from baseline in the Clinical Dementia Rating scale-Sum Box (CDR-SB) and the Mini-mental State Examination (MMSE) after 24 weeks of treatment. The secondary efficacy measurements include the Clock Drawing Test (CDT), Hopkins Verbal Learning Test (HVLT) and Ability of Daily Living (ADL).
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 |
|---|---|---|
| Qi Zhi Tong Luo group | Experimental | Drug: Qi Zhi Tong Luo capsulePatients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. Each capsule was weighted 0.5g. Qi Zhi Tong Luo capsule (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd. |
| Placebo group | Placebo comparator | Drug: PlacebosPatients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Decline in cognitive function from a prior baseline and impairment in at least 1 cognitive domain, the domain of cognition including executive function(Trail Making Test-part A(Chinese version,150s)>98s)), memory function decline (Hopkins verbal learning test free recall(36 points) <18.5 points), language function decline (Boston naming test (Chinese version 30 items)<22 points), and visuo-spatial functions (Clock drawing test(10 points)<8.5 points) ;
- Evidence of cerebrovascular disease relies on structural magnetic resonance imaging (MRI) , history and clinical feature. The neuroimaging should include at least one of following: a) a single large vessel infarction which was sufficient to cause cognition decline; b) infarction at a single strategic place was sufficient to cause severe cognition decline( the thalamus, angular gyrus, and basal ganglia, including the caudate nucleus and globus pallidus); c) multiple lacunar infarctions (≥3) outside the brainstem, or 2 lacunar infarcts at key locations, a single lacunar focus with extensive white matter lesions(WMLs) ; d) extensive and integrated WMLs(Fazekas scale≥3 points) ; e) intracranial hemorrhage in key parts, or ≥2 intracranial hemorrhages; f) combination of above.
- There was a clear temporal relationship between a vascular event and onset of cognitive deficit, cognitive impairment should appear within 3 months after a stroke, or abrupt deterioration, or stepwise progression of deficits; or cognitive impairment may be related to vascular factors, the Hachinski Ischemia scale (HIS) score ≥7;
- And the patients must have adequate vision and hearing to participate in study assessments;
- Have a stable caregiver;
Key exclusion criteria (15 listed)
- Evidence of other reasons caused cognitive impairment, like Alzheimer disease, frontotemporal dementia, Parkinson disease dementia, dementia with Lewy bodies, Huntington disease, etc;
- Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease, vitamin deficiency, or other diseases which can lead to cognitive impairment;
- Major depression (Hamilton depression rating scale [HAMD] ≥17) or other mental disorders ;
- History of drug or alcohol abuse in the past 6 month;
- History of epilepsy;
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 |
|---|---|---|
| Qi Zhi Tong Luo capsulePatients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. QZTL capsule, a traditional Chinese medicine. Each capsule was weighted 0.5g. | Drug | Qi Zhi Tong Luo group |
| PlacebosPatients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks.To preserve blinding, the placebo had an identical taste and appearance to the experimental drugs. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd. | Drug | Placebo group |
Primary outcome
Changes of Clinical Dementia Rating-Sum of the Boxes scale (CDR-SB) from baseline
Time frame: week 0, 12, 24,36
CDR-SB is a standard for disease grading in clinical studies of dementia and is used for overall endpoint assessment in clinical trials. The CDR-SB scores from 0-18 points, and a higher score indicates higher impairment.
Changes of Mini-mental State Examination(MMSE from baseline
Time frame: week 0, 12, 24,36
MMSE, 0-30 points, a lower score means severe global cognition impairment, which is used for overall endpoint assessment in clinical trials.
3 secondary outcomes
Changes of Hopkins Verbal Learning Test from baseline
Time frame: week 0, 12, 24,36
Changes of Clock drawing test from baseline
Time frame: week 0, 12, 24,36
Changes of Ability of daily living scale from baseline
Time frame: week 0, 12, 24,36
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 11 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Qi Zhi Tong Luo capsule in people with Vascular Cognitive Impairment and Qi Zhi Tong Luo Capsule, run by Dongzhimen Hospital, Beijing at 1 site 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 7 inclusion and 15 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes of Clinical Dementia Rating-Sum of the Boxes scale (CDR-SB) from baseline (time frame: week 0, 12, 24,36). 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 11 Mar 2020.