| CTRI Number |
CTRI/2025/07/091528 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relieving Frozen Shoulder: A Study on Fire Cupping and Short Wave therapy. |
|
Scientific Title of Study
|
Efficacy of Hijama Nariya and Short-Wave Diathermy in Adhesive Capsulitis (Frozen Shoulder) - An Open Label Randomized Comparative 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 |
Mohd Shuaib |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Ilaj-Bit-Tadbeer(IBT), State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9548118284 |
| Fax |
|
| Email |
raoshuaib7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Nusrat Parveen |
| Designation |
Professor |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Ilaj-Bit-Tadbeer(IBT), State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7906813040 |
| Fax |
|
| Email |
nusratparveen12755@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Shuaib |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Ilaj-Bit-Tadbeer(IBT), State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9548118284 |
| Fax |
|
| Email |
raoshuaib7@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College Himmatganj,Prayagraj, Uttar Pradesh, India Pin Code 211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College Prayagraj Uttar Pradesh |
| Address |
Department of Ilaj-Bit-Tadbeer(IBT) State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| 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 Mohd Shuaib |
State Unani Medical College & HAHRDM Hospital |
Department of Ilaj-Bit-Tadbeer(IBT), State Unani Medical College and HAHRDM Hospital Himmatganj Pryagraj Uttar Pradesh Pin code 211016
Allahabad
UTTAR PRADESH |
9548118284
raoshuaib7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical Research |
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 |
| Intervention |
Hijama Nariya |
Enrolled cases of Adhesive Capsulitis (Frozen Shoulder), after obtaining a written informed consent will be allocated with 25 patients.
Site: on affected shoulder (as mentioned below )
• 1 cup of size no.3 to be applied at skin overlying the spinous process of 7th cervical
vertebra.
• 1 cup of size no.2 to applied at the skin overlying the Infraspinatus muscle of
scapula.
• 1 cup of size no.3 to be applied at the area which lies in between the neck and the
shoulder with a slight bending to the back.
• 1 cup of size no.2 to be applied at the area which lies in the middle of the frontal
aspect of deltoid muscles when the arm is fully abducted.
Duration of Intervention: 5 minutes, on alternate day.
Duration of Protocol therapy: 28 days
Follow up: on 7th, 14th, 21st, 28th day |
| Comparator Agent |
Short-Wave Diathermy(SWD) |
Site: Affected shoulder
Patients of this group will be treated with Short Wave Diathermy(SWD). The condenser pads of
SWD will be applied on affected shoulder area with 1 or 2 inches space between skin and
pads provided by terry clothes, and left for 10 minutes. Total 14 sittings will be given on
alternate day for 28 days.
Duration of Intervention: 10 minutes
Duration of Treatment Protocol: 28 days
Follow up: on 7th, 14th, 21st, 28th day. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 40 to 60 years from all genders.
2. Clinically diagnosed cases of adhesive capsulitis (frozen shoulder) of less than 2 years with SPADI score more than or equal to 15.
3. Patients who will give consent and able to do follow up. |
|
| ExclusionCriteria |
| Details |
1. Patients with History of any trauma, fracture or surgery of glenohumeral joint.
2. Patients below 40 years and above 60 years of age.
3. Pregnant and lactating women.
4. Patients with severe systemic illness.
5. Patients with pacemaker in situ.
6. Patients taking analgesics, systemic steroids in past 01 week. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SPADI (Shoulder Pain and Disability Index) |
0,7,14,21 and 28th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QuickDASH Outcome Measure |
0,28th days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
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
|
Adhesive Capsulitis also known as Frozen Shoulder or Peri-arthritis of Gleno-humeral joint (GH), It is characterized by pain, stiffness, and restricted joint movement. Despite minimal radiographic changes, it exhibits slow, spontaneous recovery with treatment. The actual cause of Adhesive Capsulitis is often unclear but risk factors include injury, trauma, surgery, Diabetes mellitus, Hypothyroidism and Depression. It is more prevalent in individuals aged 40 to 60 years and females slightly more affected than males. Diabetics have a higher susceptibility and about 10 to 20% population of Diabetics affected. The prevalence of frozen shoulder is around 2% in general population rising to 13.4% in patients with Diabetes mellitus.Modern treatment for Adhesive Capsulitis includes NSAIDS (Non-Steroidal Anti-Inflammatory Drugs), oral corticosteroids, intra articular steroid injections and sometimes arthroscopic or open surgery. However, these methods can be expensive and It has serious adverse effects such as renal and hepatic issues and often results in low patient compliance. In the Unani System of Medicine Frozen Shoulder is known as Waja-ul-Katif or Tahajjur-e-Katif. It is sub-categorized under Waja-ul-Mafasil, a term encompassing painful or inflammatory conditions affecting joints, muscles and ligaments due to humeral alterations. Other joints specific names include Waja-ul-Warik, Waja-uz-Zahr,Waja-ur-Rakba, Tahajjur-e-Mafasil, reflecting the diverse joints it can impact. Unani system of medicine have a long history of treating Tahajjur-e-Katif (Adhesive capsulitis). Waja-ul-Mafasil is being treated by using various unani drugs and regimens of Ilaj-Bit-Tadbeer such as Fasd (venesection), Hijama (cupping), Zimaad (paste), Dalk (massage) etc. to evaluate the effectiveness of these treatment, I plan a study entitled as Efficacy of Hijama Nariya and Short-Wave Diathermy in Adhesive Capsulitis (Frozen Shoulder) – An Open Label Randomized Comparative Clinical trial.
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