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CTRI Number  CTRI/2024/03/063596 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of efficacy and safety of Polyherbal unani paste for local Application in the Management of Knee Osteoarthritis 
Scientific Title of Study   Evaluation of efficacy and safety of Dimād-e-Asfar in the Management of Knee Osteoarthritis (Waja’al-Rukba) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Almas Furquan 
Designation  MD Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  OPD No. 7 Department of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  7869469843  
Fax    
Email  almasfurqan269@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mehmooda Begum 
Designation  Professor  
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Department of Ilaj Bit Tadbeer, Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  7828895181  
Fax    
Email  mehmoodaanzar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Almas Furquan 
Designation  MD Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  OPD No. 7 Department of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  7869469843  
Fax    
Email  almasfurqan269@gmail.com  
 
Source of Monetary or Material Support  
Hakim Sayed ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 
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 Almas furquan  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital  OPD No.7 Department of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH
Bhopal
MADHYA PRADESH 		 7869469843

almasfurqan269@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diclofenac Gel  control group will be given Diclofenac gel to apply locally on the affected knee daily at bed time along with Habb-e Suranjān orally 2-tab BD for 3 weeks 
Intervention  Dimād-e- Asfar contains the following ingredients: 1) Mughas/ Maida Lakdi (Litsea glutinosa (Lour.) C. B. Robinson) 4 part 2) AambaHaldi (Curcuma amadaRoxb.) 4 part 3) SibrZard (Aloe barbadensis Mill.) 4 part 4) LodhPathani (Symplocos paniculata (Thunb.) Miq) 2 part 5) Habb-ur-Rashad (Lepidium sativum Linn.) 1 part along with Habb-e-suranjan 2 tablet BD   The test group will be given Dimād-e-Asfar in powder form to apply locally on affected knee daily at bed time along with Habb-e-Suranjān orally 2-tab BD for 3 weeks. The powdered medicines will be mixed with the lukewarm water to form a paste and the patient will be explained to use this paste on the affected knee and bandage will be wrapped to keep the test medicines in place till the desired time (overnight).In the morning the dressing will be removed and the area will be washed properly with lukewarm water. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patient fulfilling the inclusion criteria and agree to follow the protocol
2) Diagnosed cases according to American College of Rheumatology Criteria of Osteoarthritis and classified as grade II or III for OA of the knee according to Kellgren Lawrence Grading system
3) Patients with symptoms consistent with Osteoarthritis of the knee for at least six months prior to screening These symptoms include joint pain and also include crepitus swelling and/or effusion of the knee
4) At screening patients on any analgesic/anti-inflammatory medication shall be screened on visual analog scale (VAS) of pain after walking on a 50 ft flat surface of greater than 30 mm but lesser than 90 mm using a 100 mm scale If patients taking no analgesic/anti-inflammatory medication in the previous 3 days from screening then they should have VAS pain score after walking on a 50 ft flat surface of greater 40 mm but lesser 90 mm If bilateral knee pain is present the more painful knee will be selected
5) At screening and baseline if there will be bilateral OA of the knee involvement patients must have a VAS pain score after walking on a 50 ft flat surface of lesser than 30 mm in the less painful contralateral knee at the baseline assessment
6) Patient who can perform the 50-feet walk test without the support of crutches or other assistive devices
7) Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for any other condition including their knee pain
 
 
ExclusionCriteria 
Details  1) Patients participating in an experimental device study or any clinical trial within the previous 30 days prior to screening
2) Any knee surgery in the previous three months
3) Patient with Kellgren-Lawrence Grade I and grade IV OA of the knee
4) Other types of arthritis
5) Patients with any inter current disease (s) or condition (s) that may interfere with the free use and evaluation of the affected knee and may predispose them to a high probability of interfering with the completion of the 4 week follow up (neurological problems, severe congenital defects, peptic ulcer, severe liver disease, severe coronary disease, renal disease, Active Psychiatric disorder, or other clinically significant conditions)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) WOMAC Index
2) Active Range of Motion /AROM
3) Eight-meter walk test
 		 Baseline, 7th day, 14th day, 21th day, 28th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  Baseline and 28th day 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/03/2024 
Date of Study Completion (India) 04/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Osteoarthritis is the most common degenerative joint disease and a major cause of pain and disability in adult individuals. This degenerative and progressive joint disease affects around 250 million people worldwide.  Osteoarthritis is the second most common rheumatologic problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Knee osteoarthritis is classified as either primary (idiopathic) or secondary.  Major risk factors or etiologies of osteoarthritis are advancing age, female sex, past trauma, obesity, sport injury, inflammation, genetic predisposition and nutritional deficiency etc. Common clinical symptoms include chronic pain, joint instability, stiffness and radiographic joint space narrowing. 

The standard pharmacological treatment includes agents to control pain and inflammation (NSAIDs, analgesics including opioids, intraarticular corticosteroids) and the group of symptomatic slow acting drugs for osteoarthritis such as glucosamine sulphate, chondroitin sulphate, diacerein, unsaponifiable extract of soyabean and avocado administered orally as well as intraarticular hyaluronic acid administration.

The aim of the management of osteoarthritis is to control the painful signals originated from these joints, but even more, to improve physical function and quality of life. Non pharmacological therapies should always be attempted as the first line of treatment for knee osteoarthritis.
In Unani system of medicine, the term Knee osteoarthritis is not mentioned as such, however, a general term “Waja’al-Mafāsil” exists in classical text, which includes all types of arthritis. Ancient unani physicians have classified it on the basis of temperament, presence or absence of morbid material, type of morbid material involved and site of manifestations etc. Waja’al-Rukba (knee pain) is also used for the arthritis of knee as “Waja” stands for pain and “Rukba” stands for knee. So, the osteoarthritis of knee is treated on the line of treatment of Waja’al- Mafāsil described in Unani literature. There are three modes of treatment in unani system of medicine; Ilāj-bit-TadbÄ“r wa Taghzia, Ilāj-bil-Dawa and Ilāj-bil-yad. Ilāj-bit-Tadbeer includes various non-pharmacological or least pharmacological modalities which lack scientific validation in certain disorders. Among the various IBT interventions Dimād (Application of medicated paste topically) has been used by our ancient physicians in the management of different painful musculoskeletal disorders. Dimād-e- Asfar is mentioned in our literature to treat these painful/inflammatory disorders as having anti-inflammatory and analgesic effects but scientific validation is still to be done on its efficacy. Furthermore, no adverse effect is documented too about this topical formulation. Hence, this study is planned to validate its efficacy and safety in the management of Knee osteoarthritis. 

 
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