Clinical trial to evaluate the Efficacy and safety of NIMODIN IV infusion 50 ml with Nimotop IV infusion 50 ml for the treatment of intra-cerebral hemorrhage

Phase 3

Completed

• Conditions: Disorder of brain, unspecified,

• Registration Number: CTRI/2020/06/025822
• Lead Sponsor: Swiss Parenterals Ltd

Brief Summary

A Prospective,Interventional, Randomized, Doubleblind,  multi-centric, comparative Clinicaltrial to evaluate the Efficacy and safety of  NIMODIN IV infusion (Nimodipine) BP 50 ml withNimotop IV infusion (Nimodipine)50 ml for the treatment of hypertension in patients with intra-cerebralhemorrhage.

Total 80 subjects will be enrolled in the study 



Test  (n=40)  NIMODIN IV infusion (Nimodipine) BP 50 ml

Reference (n=40)  Nimotop IV infusion (Nimodipine) 50 ml



The study duration will be total 21days (Depends on patients condition around 5 days or maximum 14 days treatment+ Follow up after 21 ±3 days of completion of treatment).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-25
• Study Completion: 2022-04-22
• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Male and Female of Age: Between 18-75 years.
• 2.SAH (subarachnoid hemorrhage) which is diagnosed by the physician.
• (CTA and CT-SCAN) 3.Patients whose elevated SBP (Systolic blood pressure) at admission reached >140 mmHg. 4.The total GCS (Glasgow Coma Scale) score of 10 to 15 at time of enrollment.
• 5.CT scan demonstrated intraparenchymal hematoma with manual hematoma volume measurement ,60 mL 6.Willing to give informed consent, if patient is not in the state to give informed consent then either patients or legal representative will be responsible to give informed consent.

Exclusion Criteria

• 1.During the admission SBP >240 mmHg. 2.Intraventricular or infratentorial hemorrhage.
• 3.Clinical and radiological signs of brain herniation 4.TBI and aSAH (aneurysmal subarachnoid hemorrhage) 5.Patients with coagulopathy.
• 6.Uncontrollable irritability, pain, or other factors that affect BP.
• 7.Any history of congestive heart failure, renal failure, or liver damage.
• 8.Known sensitivity to nicardipine or nimodipine.
• 9.Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
• 10.Has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow the subject according to the protocol.
• 11.Pregnant and Breast feeding mother.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To reduce and maintain the SBP between 120 and 140 mmhg.	3 hr, 6 hr, 8 hr, 12 hr and 24 hr after initiation of infusion

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the changes of Neurological status by GCS scale.	2.To evaluate ICH values (Incidence of Hematoma expansion/volume) by CTA (Computed tomography angiography)

Trial Locations

Locations (2)

Neuro1 Stroke and Critical Care Institute,; 🇮🇳 Ahmadabad, GUJARAT, India

SPARSH Hospital and Critical Care Pvt.Ltd; 🇮🇳 Baleshwar, ORISSA, India

Neuro1 Stroke and Critical Care Institute,

🇮🇳Ahmadabad, GUJARAT, India

Dr Keyur Patel

Principal investigator

9825042505

drkeyurpatel@gmail.com