| CTRI Number |
CTRI/2020/06/025822 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/SPL/1124/101 version 01 dated 24 Nov 2019 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Keyur Krishnakant Patel |
| Designation |
Neurology and Interventional Neurologist |
| Affiliation |
Neuro1 Stroke and Critical Care Institute |
| Address |
Block - V, Mondeal Business park, NT,
Gurudwara, S.G. highway, Thaltej,
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825042505 |
| Fax |
|
| Email |
drkeyurpatel@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Harish S |
| Designation |
Director Operation |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
16 and 18, ICBio Tower Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bengaluru
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Harish S |
| Designation |
Director Operation |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
16 and 18, ICBio Tower Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bengaluru
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Swiss Parenterals Ltd |
| Address |
Ahmedabad, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Keyur Patel |
Neuro1 Stroke and Critical Care Institute, |
Block - V, Mondeal Business park, NT
Gurudwara, S.G. highway Thaltej
Ahmadabad
GUJARAT |
9825042505
drkeyurpatel@gmail.com |
| Dr Surjyaprakash Sibanarayanan Choudhury |
SPARSH Hospital and Critical Care Pvt.Ltd |
A/407, Sahid Nagar, Bhubaneswar-751007
Baleshwar
ORISSA |
9556062436
drsurjyaprakash@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Hi tech Ethics committee |
Approved |
| Institutional ethics committee sparsh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Nimotop IV infusion 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 |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •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
|
| Outcome |
TimePoints |
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
|
Baseline to EOT |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/06/2020 |
| Date of Study Completion (India) |
22/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
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 21
days (Depends on patients condition around 5 days or maximum 14 days treatment
+ Follow up after 21 ±3 days of completion of treatment). |