To confirm efficacy of Kallikrein in improvement of neurological scores in patients of acute ischemic stroke.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Mild to Moderate Acute ischemic strokeHealth Condition 2: I678- Other specified cerebrovascular diseases
- Registration Number
- CTRI/2011/07/001922
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Mild to moderate cerebral ischemic strokes presenting within
48 hours after onset of symptoms. (NIHSS score: 4-10, mild;
11-20, moderate)
2. Male or female, aged 18 to 70 years (both inclusive)
3. No hemorrhage as proved by cerebral CT scan
Exclusion Criteria
1. Mean arterial blood pressure > 180/110
2. NIHSS score: >21
3. Age <18 or >70 years
4. History of dementia or neurodegenerative disease
5. Severe comorbid condition such as cancer that would limit
survival during 3 month follow-up period
6. Women of childbearing potential
7. Peptic ulcer disease, Active bleeding diathesis, Lower GI bleed
8. Hematuria
9. Prolonged PT or PTT, Thrombocytopenia or neutropenia
10. Elevated LFT / RFT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method