| CTRI Number |
CTRI/2024/03/064651 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare whether oral baclofen or oral tizanidine is better in patients presenting with tightness of the upper limb after stroke. |
|
Scientific Title of Study
|
A study to compare efficacy of oral baclofen versus oral tizanidine in post stroke spasticity of upper limb. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSudipan Mitra |
| Designation |
Associate Professor,Department of General Medicine |
| Affiliation |
Jalpaiguri Government Medical College and d Hospital |
| Address |
Jalpaiguri Government Medical College and Hospital,Department of General Medicine,6th floor Superspeciality Building.
Jalpaiguri
WEST BENGAL
735101
India |
| Phone |
9836837658 |
| Fax |
|
| Email |
sudipanmitra_65@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudipan Mitra |
| Designation |
Associate Professor,Department of General Medicine |
| Affiliation |
Jalpaiguri Government Medical College and d Hospital |
| Address |
Jalpaiguri Government Medical College and Hospital.Department of General Medicine,Superspeciality Building ,6th floor
Jalpaiguri
WEST BENGAL
735101
India |
| Phone |
9836837658 |
| Fax |
|
| Email |
sudipanmitra_65@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSudipan Mitra |
| Designation |
Associate Professor,Department of General Medicine |
| Affiliation |
Jalpaiguri Government Medical College and d Hospital |
| Address |
Jalpaiguri Government Medical College and Hospital.Department of General Medicine,Superspeciality Building,6th floor.
Jalpaiguri
WEST BENGAL
735101
India |
| Phone |
9836837658 |
| Fax |
|
| Email |
sudipanmitra_65@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jalpaiguri Government Medical College and Hospital,Hospital Road,Jalpaiguri,West Bengal,Pin-735101 |
|
|
Primary Sponsor
|
| Name |
Jalpaiguri Government Medical College and Hospital |
| Address |
Hospital Road,Jalpaiguri,West Bengal,Pin-735101 |
| 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 |
| DrAnkita Singha Roy |
Jalpaiguri Government Medical College and Hospital |
Department of Physical Medicine and Rehabilitation,1st floor Superspeciality Building,Hospital
Road,Jalpaiguri,Pin 735101
Jalpaiguri
WEST BENGAL |
9933473616
ankusroy497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jalpaiguri Government Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral baclofen |
Oral anti-spastic drug used to reduce spasticity.
Dose 30-50mg per day in divided doses for 6months orally |
| Comparator Agent |
Oral tizanidine |
Oral anti-spastic drug used to reduce spasticity.
Dose- 4-12mg per day in divided doses for 6 months orally |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Non -diabetic |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Asthworth Scale for measurement of spasticity.Spasticity score of 2 and 3 were included. |
Visit 0(First visit)
Visit 1(At 1 month)
Visit 2(At 3 months)
Visit 3(At 6 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Action Research Arm Test for measurement of upper limb function. |
Visit 0 (First visit)
Visit 1 (At 1 month)
Visit 2 (At 3 months)
Visit 3 (At 6 months) |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/04/2024 |
| Date of Study Completion (India) |
31/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/10/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective open label randomised control trial having two arms.One group of patient receives oral baclofen for spasticity of upper limb and other group receives oral tizanidine for spasticity of upper limb following a stroke.Outcomes measured ha been analyzed through proper statistical software. Both groups have shown comparable results. |