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

A Prospective, Interventional, Randomized, Double blind, multi-centric, comparative Clinical trial to evaluate the Efficacy and safety of NIMODIN IV infusion (Nimodipine) BP 50 ml with Nimotop IV infusion (Nimodipine) 50 ml for the treatment of hypertension in patients with intra-cerebral hemorrhage.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025822

Enrollment

Registered

2020-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: NIMODIN IV infusion BP 50 ml: Nimodipine will be administered at a starting dose of 1 mg/h, and the dose will be increased by 0.5 mg/h every 10 minutes, up to a maximum of 4 mg/h Contro

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
â?¢To reduce and maintain the SBP between 120 and 140 mmhg.Timepoint: 3 hr, 6 hr, 8 hr, 12 hr and 24 hr after initiation of infusion	—

Secondary

Measure	Time frame
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) 3.To evaluate and recording the Hemodynamic indics (SBP, HR, ICP) at baseline and 24 hours monitoring after initiation of infusion) 4.Incidence of Adverse events and Serious Adverse Events throughout the trial duration Timepoint: Baseline to EOT	—

Measure

Time frame

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) 3.To evaluate and recording the Hemodynamic indics (SBP, HR, ICP) at baseline and 24 hours monitoring after initiation of infusion) 4.Incidence of Adverse events and Serious Adverse Events throughout the trial duration Timepoint: Baseline to EOT

—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026