| CTRI Number |
CTRI/2020/11/029182 [Registered on: 17/11/2020] Trial Registered Prospectively |
| Last Modified On: |
21/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to see the effect of Tinospora cordifolia in acute ischemic stroke patients. |
|
Scientific Title of Study
|
Study the clinical, biochemical, genetic and radiological profile of cerebral small vessel disease and to investigate the clinical improvement in ischemic stroke patients by Tinospora cordifolia through blinded randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Pathak |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Neuro lab, Neurology ward, 3rd floor, S S lal Hospital, Department of Neurology
IMS,BHU
Neuro lab, Neurology ward, 3rd floor, S S lal Hospital, Department of Neurology
IMS,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7499904491 |
| Fax |
|
| Email |
abhishekpathakaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Pathak |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Electrophysiology lab, in front of laser OT, S S lal hospital, Department of Neurology
IMS,BHU
Electrophysiology lab, in front of laser OT, S S lal hospital, Department of Neurology
IMS,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7499904491 |
| Fax |
|
| Email |
abhishekpathakaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Pathak |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Electrophysiology lab, in front of laser OT, S S lal hospital, Department of Neurology
IMS,BHU
Electrophysiology lab, in front of laser OT, S S lal hospital, Department of Neurology
IMS,BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7499904491 |
| Fax |
|
| Email |
abhishekpathakaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences |
| Address |
Institute of Medical Sciences, Banaras Hindu University |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priya Dev |
Sir Sunder Lal Hospital |
Neuro lab, Neurology ward, 3rd floor, Department of Neurology, S S Lal Hospital, Institute of Medical Sciences, Banaras Hindu University, Lanka, Varanasi-221005, UP, India
Varanasi
UTTAR PRADESH |
7499904491
priyadev8090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G810||Flaccid hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
This will be given to placebo group of ischemic stroke along with standard medication. Similar looking placebo capsules would be given 4 times a day for 40 days. |
| Intervention |
Tinospora cordifolia |
Its an ayurvedic herb. We are using it as an additive treatment in treatment group along with standard medication in both the groups (treatment group and placebo group). The planned intervention will be given by oral route in the doses of 400mg of Tinospora 4 times a day for 40 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years
2. Cases of Ischemic stroke with and without periventricular white matter changes.
|
|
| ExclusionCriteria |
| Details |
1. Patients denying the consent to participate.
2. Traumatic brain injury, vascular aneurysm, arterial malformation, etc.
3. History of Central Nervous System (CNS) infections.
4. Recurrent ischemic stroke
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Outcome (mRS) |
0 days and at 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIHSS, MoCA, Clinical Dementia Rating (CDR) |
0 days and 90 days |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "412"
Final Enrollment numbers achieved (India)="412" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/11/2020 |
| Date of Study Completion (India) |
31/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All consecutive acute ischemic stroke, will be recruited for the study. The patient would be randomized in two groups. Both the groups would be receiving standard treatment as per national and international guidelines and one group would receive capsules of Tinospora cordifolia and the other group would receive identical looking capsule and patient would be assessed for functional outcome at 3 months. At each level necessary blinding would be done. |