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A clinical study to assess the influence of Tongluo Recipe on patients in convalescent stage of ischemic stroke: a randomized controlled trial

Phase 1
Recruiting
Conditions
Ischemic stroke
Registration Number
ITMCTR2100004440
Lead Sponsor
Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients who accord with Western and traditional Chinese medicine diagnostic criteria for ischemic stroke;
2. Patients with early stage of convalescence that is from 2 weeks to 3 months after stroke onset;
3. Aged from 45-80 years;
4. Patients with first attack, or re-attack and the former stroke is basically recovery with no sequel;
5. Patients with NIHSS score 7-22;
6. Be volunteer to participate in clinical trial;
7. Sign the written informed consent form.

Exclusion Criteria

1. Patients with ischemic stroke induced by confirmed brain trauma, tumor, parasitosis, blood disease, heart disease, metabolic disorder, et al;
2. Patients with consciousness or language disorder affecting communication;
3. Patients with limbs activity disorder induced by joint and muscle damage affecting neurological examination;
4. Patients with severe disease including heart disease, hepatic disease, kidney disease, endocrine disease or hematopoietic disease, et al;
5. Pregnant and lactating women or mental patients;
6. Patients allergic to the ingredients contained in the Chinese medicine adopted in this clinical trial;
7. Patients participating in the other clinical trial at the same time.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
FMA;NIHSS;MoCA;inflammatory factor detection;MRI examination;
Secondary Outcome Measures
NameTimeMethod
BI;TCM symptom score;MMSE;serum lipid, hemorheology and HCY test;
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