Efficacy and Safety of Zhitan Anshen Granules in Motor Dysfunction After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Conditions
- Cerebral Infarction
- Registration Number
- ITMCTR2100004816
- 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. Meet the diagnostic criteria for cerebral infarction, and be confirmed by head CT or MRI;
2. Meet the standard of Chinese medicine stroke-qi deficiency and blood stasis syndrome type;
3. In the recovery period (the course of illness is between 2 weeks and 6 months)
4. Aged 40 to 75 years;
5. First stroke, stable vital signs, clear consciousness, able to cooperate with examination and treatment;
6. Having motor dysfunction and Fugl-Meyer score <= 84 points;
7. Sign the informed consent form.
1. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental diseases;
2. Severe disturbance of consciousness, dementia or suffering from certain diseases affect the evaluation of curative effects, such as aphasia, visual and hearing impairment;
3. Transient organic psychosis and other mental illnesses (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R standards;
4. Patients who have other diseases that affect the function of limbs, and those who have dysfunction of limbs caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment may affect nerve or functional examination;
5. Patients who are allergic to test drug components, or have a history of alcohol or drug abuse;
6. Women who are pregnant or breastfeeding, or have a pregnancy plan in the past 6 months, or cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/drugs, condoms, or removal of the vas deferens from their partners, etc.);
7. Participating in other clinical trials or participating in other drug clinical trials within 3 months.
8. Patients judged by the investigator to be unsuitable to participate in this trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fugl-Meyer upper limb rating scale;
- Secondary Outcome Measures
Name Time Method Brunnstrom stage;TCM symptom score;Modified Rankin Scale;Modified Barthel Index;