| CTRI Number |
CTRI/2024/10/075309 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Dry Cupping (Gliding Cupping)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Hijama with Roghan e Baboona in the treatmentof low back pain |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Assess the Effectiveness of Hijamah bila Shart with Roghan e Baboona in Non specific low back pain and its potential role in improving the Quality of Life in Majeedia Unani Hospital South East Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shazia Khan |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tib School of Unani Medical Education and Research Jamia Hamdard
South
DELHI
110062
India
Jamia Hamdard
New Delhi
South
DELHI
110062
India |
| Phone |
8383042803 |
| Fax |
|
| Email |
khanshazia1197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mo Usman |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard New Delhi |
| Address |
Department of Tahaffuzi wa Samaji Tib School of Unani Medical Education and Research Jamia Hamdard
South
DELHI
110062
India
Jamia Hamdard New Delhi
South
DELHI
110062
India |
| Phone |
8979968072 |
| Fax |
|
| Email |
mousman2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farkhunda Jabin |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard New Delhi |
| Address |
Department of Ilaj Bil Tadbeer School of Unani Medical Education and Research Jamia Hamdard
South Delhi
110062
India
Jamia Hamdard New Delhi
South
DELHI
110062
India |
| Phone |
7895924502 |
| Fax |
|
| Email |
drfarkhundajabin@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard
New Delhi, India
110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tib, School of Unani Medical Education and Research, Jamia Hamdard Universiry, Hamdard Nagar New Delhi- 110062 |
| 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 Shazia Khan |
Majeedia Unani Hospital |
Room NO- 10, OPD Tahaffuzi wa Samaji Tib, Jamia Hamdard University, Hamdard Nagar
New Delhi
DELHI
South
DELHI |
8383042803
khanshazia1197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional ethics Committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Habbe Suranjan |
Patients will recieve Habbe Suranjan 2 tablets twice a day orally for 2 weeks and after 2 weeks evaluation for efficacy will be recorded |
| Intervention |
Hijamah-Bila-Shart therapy with Roghan-e-Baboona |
Duration of Therapy-15 minutes
Total Sittings-7 Patients will receive hijama therapy on alternate days for two weeks and will be evaluated at baseline, at Day 14 (after completion of therapy) and at Day 21 (After one week of treatment free period) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of low back pain
2.Oswestry low back pain score up to 24 (mild to moderate disability)
3.willing to take Hijama therapy with Roghan-e-Baboona in experimental group
4. Willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Any previous spine surgery
2. Acute injury of Lumbosacral region
3. Patients with any specific causes of low back pain e.g., Vertebral fracture, herniated disc in the lumbar region, Spinal infections and spinal tumor
4. Major medical illness under treatment
5. Radiological investigation suggestive of any lower back pathology
6.Pregnant women
7. Patients with known skin disorders
8. Patients not in a condition to give valid consent
9. Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Oswestry Low back Disability Questionnaire |
At baseline at 14 Day (After completion of therapy) and at 21 Day (After one week of treatment free period) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF12V2 Quality of Life Questionnaire |
At baseline, after completion of therapy at 14 Day and after one week of treatment free period at day 21 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/10/2024 |
| 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="0"
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
|
This study is Hospital based, Randomized Controlled Trial and conducted on Patients of Non-specific low back pain from OPDs of Majeedia Unani Hospital. The patients are randomly allocated to Experimental and Control group by using alternate method. Group A (Experimental group) will receive Hijama-bila-Shart (Muzliqa/ Gliding Cupping) therapy with Roghan-e-Baboona for 15 minutes on alternate days for two weeks and Group B (Control group) will receive Standard treatment for low back pain from Ilaj-bil-Tadbeer OPD of Majeedia Unani Hospital and Patients are assessed at baseline, at Day 14 (After the completion of Therapy) and at Day 21 (After one week of treatment free period. The findings will be recorded in Case Report form designed for the study |