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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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