| CTRI Number |
CTRI/2025/07/091691 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Knee Osteoarthritis management by massage and hijama. |
|
Scientific Title of Study
|
Efficacy of Dalk Layyin Kathir With Roghan
Bedanjeer versus Hijama- Bila-Shart in Waja-ur-Rukba (Knee Osteoarthritis):A Randomised comparative clinical trial |
| Trial Acronym |
KOA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Saeb |
| Designation |
PG scholar |
| Affiliation |
State Unani Medical college |
| Address |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh
pin code 211016 State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh
pin code 211016 Allahabad UTTAR PRADESH 211016 India |
| Phone |
9719930137 |
| Fax |
|
| Email |
mohammadsaeb22@gmial.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nusrat Parveen |
| Designation |
Professor |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh pin code 211016 |
| Address |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh
Allahabad UTTAR PRADESH 211016 India |
| Phone |
7906813040 |
| Fax |
|
| Email |
nusratparveen12755@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mohd Saeb |
| Designation |
PG scholar |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh pin code 211016 |
| Address |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh
pin code 211016 State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Utter Pradesh
pin code 211016 Allahabad UTTAR PRADESH 211016 India |
| Phone |
09719930137 |
| Fax |
|
| Email |
mohammadsaeb22@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and HAHRDM and Hospital Himmatganj Prayagraj Utter Pradesh
Pin code 211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and HAHRDM and Hospital |
| Address |
Himmatganj Prayagraj Utter Pradesh
Pin code 211016 |
| Type of Sponsor |
Government medical college |
|
|
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 Saeb |
State Unani Medical College and Hospital |
Department of Ilaj Bit Tadbeer
room No 2 Ground Floor
Allahabad UTTAR PRADESH |
09719930137
mohammadsaeb22@gmial.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dalk Layyin Kathir |
Patients of Group A will be subjected to Dalk Layyin Kathir with Roghan Bedanjeer. The intervention of Dalk Layyin Kathir will be started with 20 ml of Roghan Bedanjeer on each knee joint once in a day for 15 minutes on alternate day for a period of 28 days. The patient will be asked to be seated on a massage couch and diseased area will be exposed properly. 20 ml of Roghan Bedanjeer oil will be applied over the affected site during the massage.
Dalk Layyin Kathir will be done with light stroke, having light pressure (zaeef) and slow movement (Bati) around the knee joint.
Note: Roghan Bedanjeer manufactured by Hamdard laboratories will be used in study
For Dalk Lyyin Kathir
|
| Comparator Agent |
Hijama-Bila-Shart |
The patients of Group B would be applied Hijama-Bila-shart for 10 minutes and two cups would be applied on each affected knee joint alternate day for a period of 28 days. Area of procedure would be exposed and observed appropriately for any concomitant skin lesion. The patient would be advised to be in correct sitting posture for Hijama-Bila-shart. The hairs, if found would be shaved to enable the cup to fix firmly on the joint. Two medium sized (5 cm diameter) cups would be applied on each affected knee joint in such a manner that 1st cup medially the knee joint and 2nd cup laterally the joint line. Negative pressure inside the cups would be created by drawing 2 suctions and allowed to remain adhere to the site up to 10 minutes and remove the cup and cleaned the cupped area with sterilized cotton pad or gauze. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 40-70 years from both gender.
ACR (Clinical/ radiographic classification) criteria including presence of knee pain with at least one of the following three items along with osteophytes in knee X-ray.
Age more than 50 years.
Morning stiffness less than 30 minutes
Crepitus on active motion
Patients having Knee OA of 1 and 2nd grade according to Kellgren Lawrence classification.
Patients who will give consent and able to do follow up.
|
|
| ExclusionCriteria |
| Details |
1. Participants below 40 and above 70 years of age.
2. Pregnant and lactating women.
3. Patients with severe systemic illness.
4. Patients who have received CAM therapy including analgesics, systemic/topical Steroids within last 1 month duration.
5. Other form of arthritis like rheumatoid arthritis, gout, secondary knee osteoarthritis.
6. Patient with history of trauma and accident involving knee joint.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS for knee pain |
7th, 14th, 21st, and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VOMAC |
7th,14th,21st,and 28th days |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
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)
|
04/08/2025 |
| 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
|
Knee osteoarthritis is one of the commonest rheumatological health problem across the globe. It is a degenerative joint disease of the knee which typically results from wear and tear and progressive loss of articular cartilage of the knees.(1).With a prevalence of 365 million, the knee is the most frequently affected joint, followed by the hip and the hand(2). 344 million people living with osteoarthritis experience severity levels (moderate or severe) that could benefit from rehabilitation (3). The prevalence of osteoarthritis is 22% to 39% in India. Women are more frequently affected than men. However, the prevalence is on rise due to ageing. On an average 45% of women above 65 years’ experience the symptoms. The radiological evidence is seen in 70% of the people over 65 years. Osteoarthritis is estimated to be 10th leading cause of non-fatal burden (4). Osteoarthritis is the eighth common predictor of health problem in men and fourth common predictor in women across the world (5). It is primarily treated with non-steroidal anti-inflammatory drugs(NSAIDS) and corticosteroids in modern medicine which have many adverse effects like acute renal dysfunction, fluid and electrolyte disorders, renal papillary necrosis, and nephrotic syndrome/ interstitial nephritis, etc.(6) Thus, it warrants that the safer and efficacious treatment modality should be explored for the amelioration and betterment of quality of life of the patients and Unani system of medicine has a great potential for the management of knee osteoarthritis with pharmacological and various regimental procedures. In Unani medicine, knee osteoarthritis is clinically similar with Waja-ur-Rukba, a subtype of Waja-ul-Mafasil. It has been defined as the pain and swelling of knee joints (7). It is chiefly caused by dominance of morbid phlegm in knees resulting in touting of cartilages and swelling of knee joints (8). Because of high prevalence and disease complications, now a days everyone is attracted globally towards a treatment modality with minimal or no use of drugs, and IBT, a branch of Unani system of medicine fulfils this necessity as it uses different regimens for the treatment of disease. Hijama and Dalk are regimens used in Ilaj-bit-Tadbeer to manage several diseases including Waja-ur-Rukba. These have been described in the classical literature to be effective and that too without any chance of producing side effects or minimal side effects. |