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Treatment of Mild Vascular Cognitive Impairment With Yangxue Qingnao Pill

Primary Purpose

Cerebrovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yangxue Qingnao pill
Hydergotoxine mesylate tablets
blank control group
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Diseases focused on measuring cognitive disorder

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Over 50 years old, under 85 years old, male and female, including 50 and 85 years old;
  2. The patients agreed to participate in the trial and signed the informed consent.
  3. The diagnostic criteria for vascular cognitive impairment without dementia are as follows:

    1. There are risk factors of cerebrovascular disease or the existence of cerebrovascular disease;
    2. The development of cognitive impairment was fluctuating;
    3. Mild memory impairment or retention;
    4. There is a causal relationship between cerebrovascular disease and cognitive impairment, and other diseases are excluded;
    5. The activities of daily living remained normal;
    6. 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

Exclusion Criteria:

  1. The researchers considered that it was not suitable to be included in the study;
  2. 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;
  3. 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;
  4. He had a history of acute cerebrovascular disease within 3 months;
  5. At present, there is active epilepsy;
  6. History of mental illness;
  7. Peptic ulcer and gastrointestinal bleeding;
  8. Any of the tested drugs was taken within 28 days before medication, which may cause cognitive changes and important organ damage.
  9. Accompanied by unstable blood system and immune system diseases, is not in clinical remission.
  10. Malignant tumor or intracranial tumor is known;
  11. Those who had surgery within three months or had a history of trauma.
  12. There are other advanced, serious or unstable diseases, which affect the evaluation of its efficacy and safety;

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

blank control group

treatment group(Yangxue Qingnao pill)

control group(hidezhen)

Arm Description

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment Scale (MoCA)
Level of cognition,ranging from 0-30 points, the higher score means better outcome

Secondary Outcome Measures

Full Information

First Posted
June 27, 2021
Last Updated
July 8, 2021
Sponsor
Peking University Third Hospital
Collaborators
Beijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04958512
Brief Title
Treatment of Mild Vascular Cognitive Impairment With Yangxue Qingnao Pill
Official Title
Clinical Study of Yangxue Qingnao Pill in the Treatment of Mild Vascular Cognitive Impairment Without Dementia (VCIND)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Diseases
Keywords
cognitive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blank control group
Arm Type
Other
Arm Title
treatment group(Yangxue Qingnao pill)
Arm Type
Experimental
Arm Title
control group(hidezhen)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Yangxue Qingnao pill
Intervention Description
The treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months
Intervention Type
Drug
Intervention Name(s)
Hydergotoxine mesylate tablets
Intervention Description
The control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months
Intervention Type
Other
Intervention Name(s)
blank control group
Intervention Description
There were 20 cases in the blank control group.Outpatient consultation at any time was prescribed.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment Scale (MoCA)
Description
Level of cognition,ranging from 0-30 points, the higher score means better outcome
Time Frame
at 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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 Exclusion Criteria: 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; 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100098
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Treatment of Mild Vascular Cognitive Impairment With Yangxue Qingnao Pill

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