| CTRI Number |
CTRI/2026/02/103001 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [WET CUPPING] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Wet Cupping Therapy on Different Pain Phenotypes in Knee Osteoarthritis |
|
Scientific Title of Study
|
Effect of Hijamah (Wet Cupping Therapy) on Different Pain Phenotypes in Knee Osteoarthritis: A Pilot Comparative Clinical Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/2026/jan/RRIUM/KU/2026/1EC(RO)/436/61 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Humma |
| Designation |
Research officer unani |
| Affiliation |
Regional research institute of unani medicine Srinagar |
| Address |
Regional research institute of unani medicine Srinagar, clinical department ,room no 158 habak naseembagh srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
09796550059 |
| Fax |
|
| Email |
humma.ccrum@ccrum.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Humma |
| Designation |
Research officer unani |
| Affiliation |
Regional research institute of unani medicine Srinagar |
| Address |
Regional research institute of unani medicine Srinagar, clinical department room no 158 Naseem Bagh Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
09796550059 |
| Fax |
|
| Email |
humma.ccrum@ccrum.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Humma |
| Designation |
Research officer unani |
| Affiliation |
Regional research institute of unani medicine Srinagar |
| Address |
Habak, Regional research institute of unani mediciner,clinical research ,room no 158 Naseem Bagh Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
09796550059 |
| Fax |
|
| Email |
humma.ccrum@ccrum.res.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central council for research in unani medicine |
| Address |
janak puri,opposite D block new Delhi India |
| Type of Sponsor |
Research institution |
|
|
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 Humma |
Regional research institution of unani medicine srinagar |
clinical depatmnent,room no 158,Habak, Naseem Bagh Srinagar
Srinagar
JAMMU & KASHMIR |
09796550059
humma.ccrum@ccrum.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama-bil-Shart (Wet Cupping) |
Two sessions: Day 0 and Day 14 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Clinically diagnosed knee OA
Knee pain duration 3 months or more than that
Belonging to a defined pain phenotype |
|
| ExclusionCriteria |
| Details |
Rheumatoid Arthritis, gout and septic arthritis
severe Anemia less than 9gms
bleeding disorders
intraarticular steroid injection within last 3 months |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOMAC SCORE |
2nd week ,4 week 6 weeks,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BIOMARKER EVALUATION |
BASELINE AND END OF STUDY |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
the study is done to see the effect of wet cupping on different pain phenotypes in knee osteoarthritis.we are recruiting 60 patients ,20 in each group of phenotypes and the wet cupping is to be done on day 0 and day 14.the post treatment follow up is for 2 weeks more.the total peroid of treatment is 6 weeks. effect on biomarker is also seen at the baseline and end of the study.the safety evaluation is also checked |