Health Condition 1: null- Mild to Moderate Acute ischemic stroke Health Condition 2: I678- Other specified cerebrovascular diseases
Conditions
Interventions
Intervention1: Kallikrein plus standard supportive care: 0.15PNA (para nitroaniline)OD X 10 Days IV
Control Intervention1: Placebo: OD X 10 Days
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90 Day MortalityTimepoint: Day 90 from Day 1 of IP administration;Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administrationTimepoint: Day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in disability as measured by combined Barthel Index & modified Rankin's scale.Timepoint: Day 5, day 11, day 30, day 60 and day 90 from day 1 of IP administration | — |
Countries
India
Contacts
Public ContactNaju Turakhia
Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital Sion Mumbai
Outcome results
None listed