Efficacy and Safety of Jiannao Tongluo Granules in Cognitive Impairment After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Phase 1

Recruiting

Conditions: Cerebral Infarction

Registration Number: ITMCTR2100004850

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

Inclusion Criteria

1. It meets the diagnostic criteria of cerebral infarction and is confirmed by head CT or MRI;
2. Comply with the standard of TCM stroke-wind, phlegm 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.

Exclusion Criteria

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 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;
4. Those who are allergic to test drug ingredients, or have a history of alcohol or drug abuse;
5. 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.);
6. Participating in other clinical trials or participating in other drug clinical trials within 3 months;
7. Patients judged by the investigator to be unsuitable to participate in this trial.