Stroke
Conditions
Interventions
Thrombolytic Granules:The experimental group orally administered Yangyin Tongnao Granules (provided by Zhejiang Qianshengkang Pharmaceutical Co., Ltd., specification: 5.5g per packet, batch number: 08
xiaoshuantong granule:The control group orally administered Xiaozhuan Tong granules (produced by Liaoning Xianzhen Pharmaceutical Co., Ltd., specification: 5g per packet, batch number: 080106), taking
Sponsors
Jilin Hospital of Integrative Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) In accordance with the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases (2006), the patient must meet the Western medical diagnostic criteria for atherosclerotic thrombotic cerebral infarction, with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 8 to 20.2) In line with the Diagnostic and Efficacy Evaluation Criteria for Stroke (Trial Implementation), formulated by the Encephalopathy Emergency Research Collaboration Group of the State Administration of Traditional Chinese Medicine, the patient must meet the TCM diagnostic criteria for the convalescent stage of "Zhongfeng" (stroke) with "Zhongjingluo" (meridian involvement) syndrome, and the onset of the disease must be between 2 weeks and 2 months.3) Based on the prescription composition and indications of Yangyin Tongnao Granules, and with reference to the Guiding Principles for Clinical Research on New Traditional Chinese Medicines in the Treatment of Stroke (2002 Edition), the patient must be diagnosed with "qi-yin deficiency and blood stasis obstructing collaterals" in TCM syndrome differentiation-specifically, meeting 2 major symptoms and more than 2 minor symptoms respectively. Age: 40 to 75 years old. Discontinuation of drugs for cerebral infarction treatment (except aspirin) for more than 5 half-lives (or more than 1 week for TCM medicines). The patient and their family members must provide informed consent and voluntarily participate in the trial; the process of obtaining informed consent must comply with the provisions of Good Clinical Practice (GCP).
Exclusion criteria
Exclusion criteria: 1. Patients with transient ischemic attack, lacunar infarction, intracerebral hemorrhage, and subarachnoid hemorrhage. 2. Patients with cerebral embolism, hemorrhagic infarction, asymptomatic infarction, and intracranial arteriovenous malformation. 3. Patients with concurrent brain tumors, brain trauma, or brain parasitic diseases. 4. Patients with severe primary diseases of the heart, lungs, liver, kidneys, endocrine system, or hematopoietic system. 5. Pregnant or breastfeeding women. 6. Patients legally classified as disabled (blindness, deafness, mutism, intellectual disability, mental disorders, or physical disabilities). 7. Patients with suspected or confirmed history of alcohol or substance abuse. 8. Patients with hypersensitive constitution (allergic to two or more foods or medications). 9. Patients who have participated in other drug clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological Deficit Score;Activities of Daily Living (ADL) Status (Disability Level); | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Symptom Effectiveness;Activities of Daily Living (ADL) Scale (Barthel Index);Quality of Life Index (QLI);Coagulation indicators; | — |
Countries
China
Contacts
Public ContactChangshan Ai
Jilin Hospital of Integrative Chinese and Western Medicine
Outcome results
None listed