A Multi-center, Randomized, Double-blind, Double-dummy, Parallel-controlled Positive Drug Clinical Study on the Efficacy and Safety of Mailuoning Granules in the Treatment of Stroke (Cerebral Infarction)&
- Conditions
- stroke (cerebral infarction)
- Registration Number
- ITMCTR2200006868
- Lead Sponsor
- Jiangxi Provincial People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Patients who met all of the following criteria were eligible for inclusion in the study:
1)Ages 40 to 80, regardless of gender;
2)Patients accord to diagnostic standards on western medical cerebral infarction convalescence;
3)Patients accord to syndrome differentiation criteria for stroke (cerebral infarction) convalescence (Syndromes of Stirring Wind due to Yin Deficiency) in TCM;
4)First onset of disease; Or previous history of cerebral infarction but no disability before this attack (modified Rankin scale score =1 point);
5)According to the National Institutes of Health Stroke Scale (NIHSS) score, the neurological deficit score was =7 points and =22 points;
6)Course of onset: 15~90 days from the date of onset;
7)prior to the trial, patients must give informed consent to the trial, fully understand the trial content, process and possible adverse reactions, be able to communicate with researchers well, and be able to complete the trial in accordance with the protocol provisions, and sign a written informed consent form voluntarily, and voluntarily sign a written informed consent.
Patients who met any of the following criteria were excluded from the study:
1)Patients accompany with posterior circulation cerebral infarction, lacunar cerebral infarction, transient Ischemic attack (TIA);
2)Patients suffered from cerebrovascular disease and have severe motor dysfunction before;
3)Complications affecting drug evaluation included post-stroke depression (Hamilton Depression Scale score =7), dementia, cerebral hemorrhage after cerebral infarction, etc;
4)Stroke patients confirmed by examination to be caused by brain tumors, brain trauma, hematological diseases, etc.;
5)Patients with cardiogenic cerebral embolism;
6)Patients with poor blood glucose control during screening, fasting blood glucose >11.1mmol/L, or patients with severe diabetic complications affected the efficacy assessment;
7)Patients with poor control of continuous elevated blood pressure during screening (systolic blood pressure =180 mmHg, or diastolic blood pressure =100 mmHg);
8)Patients with bleeding tendency or patients with severe bleeding within 12 weeks;
9)Patients with severe illness and coma influencing efficacy evaluation;
10)Patients who were unable to complete daily activities independently due to various other diseases and constitutions before this disease, which seriously affected the efficacy evaluation;
11)Screening patients combined with severe liver and kidney (alanine aminotransferase, aspartate aminotransferase > 1.5 times of normal, or creatinine exceeding 1.5 times of the upper limit of normal) diseases, hematopoietic system and other serious primary diseases and dysfunction; Psychiatric patients; Patients with severe rheumatic immune diseases or severe osteoarthropathy that affect motor function;
12)Patients received thrombolytic therapy within the 2 weeks prior to screening;
13)Patients used drugs known to have significant damage to the main organs within 1 month before screening;
14)Patients known to be allergic to the investigational drug (including its components);
15)People with dysphagia cannot take medicine;
16)Patients participated in clinical trials of drugs within 3 months before screening;
17)Female patients during pregnant, planning for pregnancy or lactation;
18)Other patients not specified but considered by the investigator to be not suitable for participating in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Barthel index;Improved Rankin Scale score;NIHSS score;
- Secondary Outcome Measures
Name Time Method