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

Hubei Provincial Hospital of Integrated Chinese and Western Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

发起方

Hubei Provincial Hospital of Integrated Chinese and Western Medicine