To confirm efficacy of Kallikrein in improvement of neurological scores in patients of acute ischemic stroke.

Phase 3

Completed

• Conditions: Other specified cerebrovascular diseases,

• Registration Number: CTRI/2011/07/001922
• Lead Sponsor: Bharat Serums and Vaccines Ltd

Brief Summary

The study is a randomised, placebo controlled double-blind study to determine the efficacy and safety of Kallikrein as adjuvant therapy in treatment of mild to moderate ischemic strokes at a dose of 0.15 PNA o.d for 10 days. This study will be conducted in 8-10 centers in India. The primary efficacy variables will be Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration and 90 Day Mortality. The secondary efficacy variables will be reduction in disability as measured by scores.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-05
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

• Mean arterial blood pressure > 180/110 2.
• NIHSS score: >213.
• Age <18 or >70 years4.
• 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 bleed8.
• Hematuria9.
• 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
Neurologic improvement in NIHSS at day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration	Day 5, day 11, day 30, day 60 and day 90 from Day 1 of IP administration

Secondary Outcome Measures

Name	Time	Method
Reduction in disability as measured by combined Barthel Index & modified Rankin's scale.	Day 5, day 11, day 30, day 60 and day 90 from day 1 of IP administration

Trial Locations

Locations (11)

B J Medical College and Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

KEM Hospital and Seth G.S Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

B.J.Medical College & Sassoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

GB Pant Hospital; 🇮🇳 Delhi, DELHI, India

KEM Hospital and Seth G.S Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

KEM Hospital Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

N.D.M.V.P. Samaj Medical College; 🇮🇳 Nashik, MAHARASHTRA, India

Sagar Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Seth V S Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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B J Medical College and Civil Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Asha Shah

Principal investigator

navneetasha@yahoo.com