Cerebrovascular DiseasesNCT04958512
Treatment of Mild Vascular Cognitive Impairment With Yangxue Qingnao Pill
A study testing Yangxue Qingnao pill and Hydergotoxine mesylate tablets in people with Cerebrovascular Diseases, run by Peking University Third Hospital at 1 site in China.
Trial summary
In this study, the effectiveness of vascular cognitive impairment was compared among the three groups, namely, the xidezhen group, the Yangxue Qingnao pill group and the placebo group Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cerebrovascular Diseases
- What is being tested?
- Yangxue Qingnao pill and Hydergotoxine mesylate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2017to 31 Mar 2018
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 50 years old, under 85 years old, male and female, including 50 and 85 years old;
- The patients agreed to participate in the trial and signed the informed consent.
- The diagnostic criteria for vascular cognitive impairment without dementia are as follows:
- There are risk factors of cerebrovascular disease or the existence of cerebrovascular disease;
- The development of cognitive impairment was fluctuating;
- Mild memory impairment or retention;
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- There is a causal relationship between cerebrovascular disease and cognitive impairment, and other diseases are excluded;
- The activities of daily living remained normal;
- According to the diagnostic criteria of mild cognitive impairment (MCI) developed by Xiao Shifu, the subjects' MMSE score was less than or equal to 26
Who cannot join
- The researchers considered that it was not suitable to be included in the study;
- Known liver diseases of clinical significance, which may hinder patients from completing the test, and / or total bilirubin, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase are 1.5 times higher than the upper limit of normal value;
- The patients with known clinically significant kidney disease may be prevented from completing the test, and / or the serum creatinine is higher than the normal range in the laboratory, and / or the blood urea nitrogen is 1.5 times higher than the normal range;
- He had a history of acute cerebrovascular disease within 3 months;
- At present, there is active epilepsy;
- History of mental illness;
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- Peptic ulcer and gastrointestinal bleeding;
- Any of the tested drugs was taken within 28 days before medication, which may cause cognitive changes and important organ damage.
- Accompanied by unstable blood system and immune system diseases, is not in clinical remission.
- Malignant tumor or intracranial tumor is known;
- Those who had surgery within three months or had a history of trauma.
- There are other advanced, serious or unstable diseases, which affect the evaluation of its efficacy and safety;
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100098
About this study
Official title: Clinical Study of Yangxue Qingnao Pill in the Treatment of Mild Vascular Cognitive Impairment Without Dementia (VCIND)
In this study, the effectiveness of vascular cognitive impairment was compared among the three groups, namely, the xidezhen group, the Yangxue Qingnao pill group and the placebo group
Read the detailed description
The risk factors of various cerebrovascular diseases (atherosclerosis, stroke, hypertension, coronary heart disease, atrial fibrillation, dyslipidemia, diabetes mellitus) are both risk factors of Alzheimer's disease and one of the many causes of vascular dementia. There are many manifestations of mental retardation caused by cerebrovascular diseases. The most prominent aspect is cognitive and behavioral impairment, which is characterized by mental retardation, forgetfulness, misunderstanding and poor calculation ability. Yangxue Qingnao pill (z20063808:) is produced by Tianshili Pharmaceutical Group Co., Ltd, And then improve the ability of learning and memory. Some clinical application results show that the drug can significantly improve the cognitive and behavioral ability of patients with ischemic stroke, improve the cognitive function of patients with mild Alzheimer's disease, and improve the quality of life. Therefore, this study mainly compared the effectiveness of treatment of vascular cognitive impairment in three groups, namely, the xidezhen group, the yangxueqingnaowan group and the placebo group.
- Conditions
- Cerebrovascular Diseases
- Being tested
- Yangxue Qingnao pill, Hydergotoxine mesylate tablets, blank control group
- Keywords
- cognitive disorder
- Medical subject headings
- Cerebrovascular Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxue Qingnao pillDrug
The treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months
Hydergotoxine mesylate tabletsDrug
The control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months
blank control groupOther
There were 20 cases in the blank control group.Outpatient consultation at any time was prescribed.
| Study group | Role | What they receive |
|---|---|---|
| blank control group | Other | Not described Receives: Other: blank control group |
| treatment group(Yangxue Qingnao pill) | Experimental | Not described Receives: Drug: Yangxue Qingnao pill |
| control group(hidezhen) | Active comparator | Not described Receives: Drug: Hydergotoxine mesylate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Scale (MoCA)
Level of cognition,ranging from 0-30 points, the higher score means better outcome
Measured: at 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start30 Aug 2017
- Primary completion31 Jan 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958512
- Sponsor's protocol ID
- M2017154
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Yangxue Qingnao Pill in the Treatment of Mild Vascular Cognitive Impairment Without Dementia (VCIND)
- ClinicalTrials.gov ID
- NCT04958512
- Acronym / sponsor ID
- M2017154
- Conditions
- Cerebrovascular Diseases
- Keywords
- cognitive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 12 Jul 2021 (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.
In this study, the effectiveness of vascular cognitive impairment was compared among the three groups, namely, the xidezhen group, the Yangxue Qingnao pill group and the placebo group
Detailed description
The risk factors of various cerebrovascular diseases (atherosclerosis, stroke, hypertension, coronary heart disease, atrial fibrillation, dyslipidemia, diabetes mellitus) are both risk factors of Alzheimer's disease and one of the many causes of vascular dementia. There are many manifestations of mental retardation caused by cerebrovascular diseases. The most prominent aspect is cognitive and behavioral impairment, which is characterized by mental retardation, forgetfulness, misunderstanding and poor calculation ability. Yangxue Qingnao pill (z20063808:) is produced by Tianshili Pharmaceutical Group Co., Ltd, And then improve the ability of learning and memory. Some clinical application results show that the drug can significantly improve the cognitive and behavioral ability of patients with ischemic stroke, improve the cognitive function of patients with mild Alzheimer's disease, and improve the quality of life. Therefore, this study mainly compared the effectiveness of treatment of vascular cognitive impairment in three groups, namely, the xidezhen group, the yangxueqingnaowan group and the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| blank control group | Other | Other: blank control group |
| treatment group(Yangxue Qingnao pill) | Experimental | Drug: Yangxue Qingnao pill |
| control group(hidezhen) | Active comparator | Drug: Hydergotoxine mesylate tablets |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 50 years old, under 85 years old, male and female, including 50 and 85 years old;
- The patients agreed to participate in the trial and signed the informed consent.
- The diagnostic criteria for vascular cognitive impairment without dementia are as follows:
Key exclusion criteria (12 listed)
- The researchers considered that it was not suitable to be included in the study;
- Known liver diseases of clinical significance, which may hinder patients from completing the test, and / or total bilirubin, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase are 1.5 times higher than the upper limit of normal value;
- The patients with known clinically significant kidney disease may be prevented from completing the test, and / or the serum creatinine is higher than the normal range in the laboratory, and / or the blood urea nitrogen is 1.5 times higher than the normal range;
- He had a history of acute cerebrovascular disease within 3 months;
- At present, there is active 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 |
|---|---|---|
| Yangxue Qingnao pillThe treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months | Drug | treatment group(Yangxue Qingnao pill) |
| Hydergotoxine mesylate tabletsThe control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months | Drug | control group(hidezhen) |
| blank control groupThere were 20 cases in the blank control group.Outpatient consultation at any time was prescribed. | Other | blank control group |
Primary outcome
Montreal Cognitive Assessment Scale (MoCA)
Time frame: at 6th month
Level of cognition,ranging from 0-30 points, the higher score means better outcome
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 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Dongsheng Fan principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yangxue Qingnao pill and Hydergotoxine mesylate tablets in people with Cerebrovascular Diseases, run by Peking University Third Hospital 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 9 inclusion and 12 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 12 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Montreal Cognitive Assessment Scale (MoCA) (time frame: at 6th month). 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 12 Jul 2021.