Treatment of Mild Vascular Cognitive Impairment With Yangxue Qingnao Pill

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

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Diseases
• Intervention / Treatment: Other: blank control group; Drug: Yangxue Qingnao pill; Drug: Hydergotoxine mesylate tablets

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100098
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: blank control group	Other: blank control group; There were 20 cases in the blank control group.Outpatient consultation at any time was prescribed.
EXPERIMENTAL: treatment group(Yangxue Qingnao pill)	Drug: Yangxue Qingnao pill; The treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months
ACTIVE_COMPARATOR: control group(hidezhen)	Drug: Hydergotoxine mesylate tablets; The control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment Scale (MoCA)	Level of cognition,ranging from 0-30 points, the higher score means better outcome	at 6th month

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2017
• Primary Completion (ACTUAL): January 31, 2018
• Study Completion (ACTUAL): March 31, 2018

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (ACTUAL): July 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: cognitive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Cerebrovascular Disorders
• Other Study ID Numbers: M2017154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No