| CTRI Number |
CTRI/2026/03/105818 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of massage cupping in pain and stiffness of shoulder joint |
|
Scientific Title of Study
|
A Case Series to evaluate the efficacy of Hijamah Dalkiyya (gliding cupping) with Roghan Haft Barg 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 |
Ms Umama |
| Designation |
BUMS Final Prof. Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room No. 11, Ground Floor, School of Unani Medical Education and Research, Jamia Hamdard
South
DELHI
110062
India |
| Phone |
9354197058 |
| Fax |
|
| Email |
syeda.umama.jh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Umama |
| Designation |
BUMS Final Prof. Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room No. 11, Ground Floor, School of Unani Medical Education and Research, Jamia Hamdard
South
DELHI
110062
India |
| Phone |
9354197058 |
| Fax |
|
| Email |
syeda.umama.jh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadia Nikhat |
| Designation |
Assistant Professor (Supervisor) |
| Affiliation |
Jamia Hamdard |
| Address |
Dept. of Ilaj bit Tadbeer, Room No. 11, Ground Floor, School of Unani Medical Education and Research, Jamia Hamdard
South
DELHI
110062
India |
| Phone |
9990098725 |
| Fax |
|
| Email |
sadianikhat@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD)
A G’s Colony Road, Opposite ESI Metro Station, Hyderabad-500038
Telangana State, India
Email: spurccrum@gmail.com
Phone no: 9776355133 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jamia Hamdard |
Jamia Hamdard, New Delhi 110062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Umama |
Majeedia Unani Hospital, Jamia Hamdard |
Room No. 21, Ilaj bit Tadbeer Unit
South
DELHI |
9354197058
syeda.umama.jh@gmail.com |
|
|
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: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gliding cupping with placebo (liquid paraffin) |
Gliding cupping with liquid paraffin for 10 minutes daily will be done for 10 days |
| Intervention |
Gliding cupping with Roghan Haft Barg |
Gliding cupping with Roghan Haft Barg for 10 minutes daily will be done for 10 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with shoulder joint pain and limited mobility of shoulder, at stiffness stage
Mild to moderate pain on visual analogue scale
Willing to sign informed consent |
|
| ExclusionCriteria |
| Details |
Patients with severe co-morbidities and unstable medical conditions
Tenderness, trauma, or bone lesions or injury to shoulder
Pregnant and lactating mothers
Patients who received corticosteroids or any other intra-articular injection within past 6 weeks
History of allergy to oils or topical drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in VAS
Improvement in SPADI
Increased Range of Motion (on Goniometer) |
6th Day, 10th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in VAS |
6th Day, 10th Day |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/03/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Adhesive Capsulitis of the shoulder (ICD-11: FB53.0), commonly referred to as ‘Frozen shoulder’ is a condition associated with stiffness and pain in the shoulder joint. In Unani medicine, the term Tahajjur-wa-Salabat-e-Mafasil (stiffness of joints) is used to describe the condition in which joint mobility is decreased, which usually occurs as a consequence of Waja al Mafasil (osteoarthritis). This randomized case series aims to evaluate the therapeutic effect of Hijamah Dalkiyya (gliding cupping) with Roghan Haft Barg in comparison to Hijamah Dalkiyya with placebo (liquid paraffin) in patients of frozen shoulder. We intend to include 12 patients aged 30-60 years, diagnosed with Frozen shoulder. The patients will be randomly divided into two groups, A & B (06 patients in each group). Group A (Test group) will undergo Hijamah Dalkiyya (gliding cupping) with Roghan Haft Barg, while Group B (Control group) will undergo Hijamah Dalkiyya with placebo (liquid paraffin). Both groups will receive 10 sessions of the therapy for 10 minutes daily. Efficacy will be assessed with Visual Analogue Scale (VAS), Shoulder Pain and Disability Index (SPADI), and Range of Motion (assessed with Goniometer in Abduction, Extension, and Flexion). Safety will be monitored through pre- and post-treatment investigations. The study aims to assess the comparative efficacy of Hijamah Dalkiyya (gliding cupping) with Roghan Haft Barg compared to Hijamah Dalkiyya (gliding cupping) with placebo. The results of the study will help in exploring and substantiating the principles of Unani medicine in which har mizaj (hot temperament) drugs, especially those recommended in Waja al Mafasil barid (osteoarthritis caused by cold temperament) are prescribed in the treatment of frozen joints. |