| CTRI Number |
CTRI/2025/01/079541 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Massage and Dry Cupping in Hemiplegia |
|
Scientific Title of Study
|
Comparative efficacy of Hijama bila shart versus Dalk-i-sulb with Roghan-e-Haft barg in motor recovery of Falij-e-nisfi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zarrin Gauhar Shaikh Asif |
| Designation |
PG Scholar Department of Ilaj bit tadabeer |
| Affiliation |
National Institute Of Unani Medicine Bangalore |
| Address |
Department of Ilaj bit tadabeer National Institute of Unani Medicine ,Kottigepalya ,Magadi main road Bangalore
KARNATAKA
560091
INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
8237396582 |
| Fax |
|
| Email |
zarrin.gauharmlg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit tadabeer, National Institute Of Unani Medicine, Kottigepalya, Magadi main road , Bangalore
Bangalore
KARNATAKA
560091
INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit tadabeer, National Institute Of Unani Medicine, Kottigepalya, Magadi main road , Bangalore
Bangalore
KARNATAKA
560091
INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Unani Medicine Magadi Main Road Kottigepalya Bengaluru 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine Kottigepalya , Magadi Main Road , Bangalore 560091 , KARNATAKA India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Zarrin Gauhar Shaikh Asif |
National Institute Unani Medicine |
Department of Ilaj bit
Tadbeer , OPD 28,
National Institute of
Unani Medicine,
Kottigepalya, Magadi
Main Road, 560091
Bangalore
KARNATAKA |
8237396582
zarrin.gauharmlg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication Of Decision Of the Institutional Ethics Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dalk-i-sulb |
Patients will receive Dalk-i-sulb with 25 ml of Roghan-e-Haft Barg daily for a duration of 30 minutes for 30 days over the vertebral column and paralysed limbs (total 30 sittings). |
| Intervention |
Hijama bila shart |
Hijama bila shart will be performed as per standard operating procedure using fibre cups of medium size on origins of muscles of paralyzed extremities for a duration of 10 minutes, every third day till the 30th day of the study. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
o Radiologically and clinically diagnosed cases of Hemiplegia (Falij-e-nisfi)
secondary to stroke
o Age 25 to 65 years
o Either Genders
o Presentation of unilateral stroke between 3 months to 5 years
o Clinically and haemodynamically stable patients
o Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
o Patient less than 25 years and more than 65 years.
o Patients with terminal medical conditions such as Cancer
o Patients of liver, kidney, cardiac and other co-morbidities
o Pregnant and lactating women
o Other significant upper limb and lower limb impairment e.g. fracture within six months, severe arthritis and amputation
o Evidence of fixed contracture
o Patients with uncontrolled systemic diseases.
o Unwillingness or inability to complete the requirements of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl Meyer Assessment Scale |
0-15-30 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barthel ADL index |
0-15-30 day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Purpose: Comparative Efficacy of Hijama bila shart versus Dalk-i-sulb with Roghan-e-Haft Barg in motor recovery of Falij-e-nisfi.
Study design: Open lablled , randomized comparative clinical study
Intervention: In Test group Hijama bila shart will be performed as per standard operating procedure using fibre cups of medium size on origins of muscles of paralyzed extremities for a duration of 10 minutes, every third day till the 30th day of the study. (total 10 sittings).The patients in control group will receive Dalk-i-sulb with 25 ml of Roghan-e-Haft Barg daily for a duration of 30 minutes for 30 days over the vertebral column and paralysed limbs (total 30 sittings). Main outcome measure: Primary outcome measure -Fugl Meyer Assessment Scale Secondary outcome measure-Barthel ADL index |