Jiannao tongluo granules for convalescent cerebral infarction: a randomized controlled, double-blind trial

Phase 1

• Conditions: cerebral Infarction

• Registration Number: ITMCTR2100005030
• Lead Sponsor: Xinhua Hospital Affiliated to Hubei University of Traditional Chinese Medicine/Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of ''cerebral infarction'' and be confirmed by head CT or MRI examination;
2. Meet the standard of traditional Chinese medicine for stroke - wind-phlegm stasis syndrome;
3. In the recovery period (the course of the disease 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 the patient can cooperate with the examination and treatment;
6. Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria

1. Patients with severe cardiovascular and cerebrovascular, liver, kidney, malignant tumors, blood system diseases, and mental diseases;
2. Severe disturbance of consciousness, dementia or certain diseases that affect the evaluation of curative effect, such as aphasia, audio-visual impairment;
3. Transient organic psychosis and other psychotic disorders (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R criteria;
4. Patients with other diseases that affect the function of limb movement, and those with limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc., which may affect the nerve or functional examination before treatment;
5. Those who are allergic to the components of the test drug, or have a history of alcohol or drug abuse;
6. Patients who are pregnant or breastfeeding, or who plan to become pregnant within the past 6 months, or who cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/dose, condoms, or partner removal of the vas deferens, etc.);
7. Those who are participating in other clinical trials or have participated in other drug clinical trials within 3 months;
8. Patients who are 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
ational Institute of Health Stroke Scale Score;

Secondary Outcome Measures

Name	Time	Method
TCM Symptom Score;Modified Rankin Scale Grading;Fugl-Meyer Assessment Scale Score;Modified Barthel Index, MBI;Montreal Cognitive Assessment (MoCA) Score;