Efficacy and Safety of Zhitan Anshen Granules in Cognitive Impairment After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Conditions
- Cerebral Infarction
- Registration Number
- ITMCTR2100004803
- Lead Sponsor
- Hubei Provincial Hospital of Integrated Chinese and Western Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. It meets the diagnostic criteria of cerebral infarction and is confirmed by head CT or MRI;
2. Meet the standard of Chinese medicine stroke-qi deficiency and blood stasis syndrome;
3. In the recovery period (the course of illness is 2 weeks to 6 months);
4. Aged 40 to 75 years;
5. For the first time, the vital signs are stable, the consciousness is clear, and they can cooperate with the examination and treatment;
6. The subject has an education level of elementary school or above, and is capable of completing cognitive function assessment;
7. Montreal Cognitive Assessment Scale (MoCA) score < 26 points;
8. Volunteer to participate in this study and sign an informed consent.
1. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental illnesses;
2. Temporary organic psychosis and other mental diseases (such as depression, schizophrenia), or other mental disorders that meet DSM-IV-R standards;
3. There are other diseases that affect the function of the limbs, and those with limb dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment may affect nerve or functional examination;
4. Those who are allergic to the components of the tested drug, or have a history of alcohol or drug abuse;
5. Women who are pregnant or breastfeeding, or have pregnancy plans in the past 6 months, or who cannot take effective contraceptive measures (sterilization, long-term use of contraceptives/drugs, condoms, or removal of the vas deferens from their partners, etc.);
6. Participated in other clinical trials or other drug clinical trials within 6.3 months.
7. The investigator judged that it is not suitable for patients participating in this trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Montreal Cognitive Assessment (MoCA);
- Secondary Outcome Measures
Name Time Method Modified Barthel Index, MBI;Modified Rankin Scale;event-related potential-P300;TCM symptom score;National Institute of Health Stroke Scale;