| CTRI Number |
CTRI/2024/08/071801 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Sciatica by Cupping therapy |
|
Scientific Title of Study
|
An Open label, Randomized, Comparative Clinical Study to Evaluate the Efficacy of Hijamah bil shart (wet cupping) at Two Different Sites in the Management of Sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Faisal Khan |
| Designation |
PG Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Deptt. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard
South
DELHI
110062
India |
| Phone |
8448422053 |
| Fax |
|
| Email |
faisalkhancoolboy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Wasi Akhtar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Deptt. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard
South
DELHI
110062
India |
| Phone |
9027570265 |
| Fax |
|
| Email |
drmdwasiakhtar@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Wasi Akhtar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Deptt. of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard
South
DELHI
110062
India |
| Phone |
9027570265 |
| Fax |
|
| Email |
drmdwasiakhtar@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard (Deemed to be University), New Delhi |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard univrsity |
| Address |
Hamdard Nagar, New Delhi, 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 Md Wasi Akhtar |
Jamia Hamdard |
Moalajat OPD, Majeedia Unani Hospital, School of Unani Medical Education and Research
South
DELHI |
9027570265
drmdwasiakhtar@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hijamah bil shart at lower most points |
Hijamah bil shart (wet cupping) will be done by placing 1 cup over calf muscle, and 1 cup below lateral malleolus of the affected leg |
| Intervention |
Hijamah bil shart at LS Spine |
Hijamah bil shart (wet cupping) will be done with 2 cups placed paravertebral area at L4-L5 or L5-S1 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age- 18 to 65 years.
All genders.
Already diagnosed patients of sciatica(chronic cases) having constant pain since 3 months or more presenting with all or some of the following signs and symptoms.
Unilateral leg pain greater than low back pain radiating towards leg/ foot/toes.
Numbness and/ tingling sensation in the same distribution.
Positive straight-leg-raising test.
Pain intensity score of 30-60 mm on a 100-mm visual analog scale (VAS).
Willingness to accept wet cupping intervention
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patients of previous back surgery or lumbar spine surgery.
Patients of spinal tumors, gross or fixed developmental deformity, cauda equine or vertebral fracture.
Pelvic or Back trauma.
Rheumatoid Arthritis.
Ankylosing spondylosis.
Patients of bleeding disorders.
Patients of anaemia (Hb less than 10 gm)
Patients with Chronic liver, kidney or heart disease
Motor weakness or Muscle wasting
Patients suffering from Psychiatric disorders
HCV and HBsAg positive patients
History of stroke, severe hypertension and uncontrolled diabetes mellitus
Unwilling to participate in the study. |
|
|
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 |
Reduction in Pain intensity and other symptoms of Sciatica.
Improvement in Range of motion of hip joint |
Day 1 and Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in time to climb stairs.
An increase in distance covered in 6 minutes walk on plain surface |
Day 1 and Day 42 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
01/09/2025 |
| Date of First Enrollment (Global) |
01/09/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
Diagnosed patients of Sciatica, fulfilling the inclusion and exclusion criteria, will be enrolled in the study. A written informed consent will be obtained from each patient before enrolment. Afterwards, patients will be randomized by block randomization into either of the two groups, Group A and Group B for therapeutic intervention Hijamah bil Shart. Patients of Group A will receive Hijamah bil Shart over Lumbosacral region. 2 cups will be placed on paravertebral area at L4-L5 or L5-S1 for Hijamah. Patients of Group B will receive Hijamah bil Shart over calf muscle and below lateral malleolus of the affected leg. There will be 3 sittings of Hijamah fortnightly in both groups. The patients will be assessed on assessment parameters viz. SLR, MSBQ, SBI, VAS, Goniometer, 6 minutes walk test and, Stair climbing test before and after treatment. There will be a last follow-up on day 42 for assessment only, and no therapy will be given on this day. |