| CTRI Number |
CTRI/2024/07/070807 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study of Massage and Dry Cupping in Shoulder Pain |
|
Scientific Title of Study
|
A randomized Comparative clinical trial on the efficacy of Dalk Mutadil (moderate massage) with Rogan-e-Baboona vs. Hijama bila shart (cupping without scarification) in frozen shoulder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammed Waseem |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Government, Unani Medical College,
Dept.: Ilaj bit Tadbeer,
Room No. 103
Anna Hospital campus,
P.H. Road, Arumbakkam,
Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9841383785 |
| Fax |
|
| Email |
drmohammedwaseem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muhammad Javeed |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Government, Unani Medical College,
Dept.: Ilaj Bit Tadbeer
Room No. 103
Anna Hospital campus,
P.H. Road, Arumbakkam,
Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9600129326 |
| Fax |
|
| Email |
pggumc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nizamudeen S |
| Designation |
Associate Professor |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Government, Unani Medical College,
Dept.: Ilaj Bit Tadbeer,
Room No. 103
Anna Hospital campus,
P.H. Road, Arumbakkam,
Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
8754404152 |
| Fax |
|
| Email |
drnizamgumc@gmail.com |
|
|
Source of Monetary or Material Support
|
| AAGHIM.
Anna Hospital Campus,
Arumbakkam,
Chennai, 600106. |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College Chennai |
| Address |
Government Unani Medical College,
Anna Hospital Campus,
P.H. Road, Arummbakkam,
Chennai - 600106
|
| 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 |
| Dr Mohammed Waseem |
Govt Unani Medical College, |
Government, Unani Medical College,
Dept. Ilaj Bit Tadbeer,
Room No.: 103
Arumbakkam,
chennai 106
Chennai
TAMIL NADU |
9841383785
drmohammedwaseem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Commitee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ḤijÄma bilÄ Shará¹ |
20 days for about 10 minutes on every alternate day.
with 3 medium-sized cups on the points, including Subscapularis, Deltiod, and Middle Trapezius on the affected shoulders |
| Comparator Agent |
Dalk Mu‘tadil with Roghan-e-Babunah
|
25ml of Roghan e Babunah for 20 days for about 15 minutes on every alternate day on affected shoulders
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of all genders will be selected for the study.
2. Age between 40 to 60 years.
3. Painful and difficult (unilateral or bilateral) shoulder mobility.
4. The duration of the symptoms exceeds four months.
5. Frozen Shoulder cases with a clinical diagnosis.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 40 and above 60 years of age.
2. Pregnant and lactating mothers.
3. H/O Shoulder injury and surgery, local corticosteroid injections within the previous four months, or current corticosteroid medication.
4. Patients who fail to give consent.
5. Fracture or dislocation of the affected shoulder.
6. A history of any systemic, metabolic, or infectious diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of life - Shoulder pain and disability
index scale (SPADI).
Relief in Pain Visual Analogue Scale (VAS)
|
20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life (SPADI) |
20 days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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 Applicable |
| 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
|
A randomized comparative clinical trial on the efficacy of Dalk Mu’tadil (moderate massage) with Rogan-e-Babunah vs. Hijama bila shart (cupping without scarification) in frozen shoulder. Duration : 20 days Sample Size : 30 IEC No: GUMC/IEC/2022-2023/MJ/23/06 Out Comes: Primary
Outcome: Improvement
in AROM (Goniometer).
Improvement in Quality of life - Shoulder pain and disability
index scale (SPADI).
Secondary Outcome: Relief in Pain Visual Analogue Scale (VAS). Objective of the Study: To assess the
clinical efficacy of Dalk Mu‘tadil with Roghan-e-Babunah and ḤijÄma
bilÄ Shará¹ in Frozen shoulder patients. |