| CTRI Number |
CTRI/2025/03/083556 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Dry Cupping Therapy and Habbe Asgand in the Management of Low Back Pain |
|
Scientific Title of Study
|
A Comparative Study of Hijamah Bila (Shurt Dry Cupping) Vs Habbe Asgand in the Management of Waja-uz-Zahr (Low Back Pain) An Open Label Randomized Controlled Clinical Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahid Amam |
| Designation |
PG Scholar |
| Affiliation |
Government Tibbi College and hospital |
| Address |
PG Block 4th floor Room Number 26 department of Moalajat Government Tibbi College and Hospital Budh Murti Kadamkuan
Patna
BIHAR
800003
India |
| Phone |
8409713439 |
| Fax |
|
| Email |
simam35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Najibur Rahman |
| Designation |
Associate Professor cum HOD |
| Affiliation |
Government Tibbi College and Hospital |
| Address |
PG Block 4th floor Room Number 25 Department of Moalajat Government Tibbi College and Hospital Budh Murti Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
9122332101 |
| Fax |
|
| Email |
dr.md.najibur.rahman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Razi Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Government Tibbi College and Hospital |
| Address |
PG Block 4th floor Room Number 30 Department of Moalajat Government Tibbi College and Hospital Budh Murti Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
7909035622 |
| Fax |
|
| Email |
dr.razi.ahmed91@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD Room Number 29 Department of Moalajat Government Tibbi College and Hospital Budh Murti Kadamkuan Patna Bihar India pin code 800003 |
|
|
Primary Sponsor
|
| Name |
Government Tibbi College and Hospital Kadamkuan Patna |
| Address |
Budh Murti Kadamkuan Patna Bihar India Pin code 800003 |
| 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 Md Najibur Rahman |
Government Tibbi College and Hospital |
OPD Room Number 29 Department of Moalajat Government Tibbi College and Hospital Budh Murti Kadamkuan Patna pin code 800003
Patna
BIHAR |
9122332101
dr.md.najibur.rahman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Habbe Asgand |
Habbe Asgand orally two pills (each 650mg) twice a day after meal for 14 days |
| Intervention |
Hijamah-Bila-Shurt (dry cupping) |
Hijamah-Bila-Shurt (dry cupping) Total number of 4 cups of size 5.5 cm diameter each will be applied locally on lumbosacral region on each side of vertebral column for 20 minutes alternate day for 14 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and radiologically diagnosed patients of Low Back Pain.
Willingness to participate in the study and give written consent.
|
|
| ExclusionCriteria |
| Details |
History of any major trauma.
History of any major systemic illness like diabetes mellitus, hypertension, CVD, CVA etc.
Pregnant and lactating women.
Prolapsed of intervertebral disc.
Low back pain secondary to a malignant or autoimmune disease.
Congenital deformities of the spine (except lordosis)
Any skin disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Oswestry Low Back Pain Scale |
at baseline i.e. 00th day (Visit 1) , 7th (Visit 2) and 14th day (Visit 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of Visual Analogue Scale |
at baseline i.e. 00th day (Visit 1) , 7th (Visit 2) and 14th day (Visit 3) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/04/2025 |
| 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="0"
Months="0"
Days="21" |
|
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
|
|