Efficacy and Safety of Jiannao Tongluo Granules in Motor Dysfunction After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Conditions
- stroke
- Registration Number
- ITMCTR2100004804
- 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. Comply with the standard of stroke-wind, phlegm and blood stasis syndrome in traditional Chinese medicine;
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. There is obvious motor dysfunction, Fugl-Meyer score <=84 points;
7. Volunteer to participate in this study and sign an informed consent form.
1. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental illnesses;
2. Transient organic psychosis and other mental illnesses (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R standards;
3. Those who are allergic to test drug ingredients, or have a history of alcohol or drug abuse;
4. Women who are pregnant or breastfeeding, or have a pregnancy plan within the past 6 months, or who cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/drugs, condoms, or removal of the vas deferens from their partners, etc.);
5. Participating in other clinical trials or participating in other drug clinical trials within 3 months;
6. The investigator judges the patients who are not suitable 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 TCM symptom score;Modified Rankin Scale;Motor Evoked Potential;National Institute of Health Stroke Scale;Modified Barthel Index;