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CTRI Number  CTRI/2021/08/036008 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 25/08/2021
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   The Efficacy and Safety of Habb-i Dard-i Mafasil in Waja‘ al-Mafāṣil (Osteoarthritis) 
Scientific Title of Study   A Prospective, Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of Habb-i Dard-i Mafasil in Waja‘ al-Mafāṣil (Osteoarthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kainat mahmood 
Designation  pg scholar 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department of moalajat ,New opd block, National Research Institute Of Unani Medicine For Skin Disorders, AG colony Road, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8274888404  
Fax    
Email  mh8009222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Qamar Uddin 
Designation  professor and HOD of Moalajat 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department of moalajat ,New opd block, National Research Institute Of Unani Medicine For Skin Disorders, AG colony Road, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Qamar Uddin 
Designation  professor and HOD of Moalajat 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department of moalajat ,New opd block, National Research Institute Of Unani Medicine For Skin Disorders, AG colony Road, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute Of Unani Medicine For Skin Disorders,AG colony Road,erragadda hyderabad 
 
Primary Sponsor  
Name  National research institute of Unani medicine for skin disorders 
Address  National research institute of Unani medicine for skin disorders,opp ESI hospital,AG colony Road,erragadda hyderabad 500038 
Type of Sponsor  Research institution and hospital 
 
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 
kainat mahmood  National Research Institute Of Unani Medicine For Skin Disorders,AG colony Road,erragadda hyderabad  Department of moalajat ,New opd block, National Research Institute Of Unani Medicine For Skin Disorders, AG colony Road, Erragadda, Hyderabad 500038
Hyderabad
TELANGANA 		 7003361038

mh8009222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee CRIUM ,Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A:Habb-i Dard-i Mafasil   Patients will be given Habb-i Dard-i Mafasil in the dose of 2 pills (500 mg each) twice daily orally with water after meals  
Comparator Agent  Group B:Aceclofenac 100mg  Patients will be given aceclofenac in the dose of 1 tab (100 mg each) twice daily orally with water after meals  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants of any gender aged between 40 and 65 years
2. Clinical and Radiographic Knee Osteoarthritis as per the following
American College of Rheumatology (ACR) criteria:
a. Knee Pain
b. Osteophytes on Knee Radiograph, and
c. At least 1 of the following 3 criteria:
i. Age ≥40 years (revised as per Sl. No. 1)
ii. Morning Stiffness lasting ≤30 minutes
iii. Crepitus on Active Knee Motion
3. Knee OA of Kellgren-Lawrence Grade 1 to 3
4. Body Mass Index (BMI): <40 kg/m2
5. Willing to come for regular follow-up visits for entire duration of the study
6. Ability to provide Written Informed Consen 
 
ExclusionCriteria 
Details  1. Age <40 years and >65 years
2. Knee OA of Kellgren-Lawrence grade IV
3. BMI ≥40
4. Patients with Knee Joint Effusion
5. Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing
spondylitis, psoriatic arthritis, gout), or any other type of arthritis
6. Patients on long-term steroid treatment
7. H/o having received intra-articular knee injection (corticosteroids or
hyaluronan), or any investigational drug in the previous one month
8. Any significant systemic diseases (cardiovascular, gastrointestinal,
hepatic, renal, neurologic or psychiatric disorder)
9. Known hypersensitivity to study drug or any of its ingredients
10.Pregnant and lactating women
11.H/o addiction (alcohol, drugs)
12.Unwilling to come for regular follow-up for entire duration of the study
13.Patients considered not eligible in the Investigator’s opinion during the
study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The response to
treatment will be assessed using the following parameters:
1. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis
Index
2. Visual Analogue Scale (VAS)
3. Joint Tenderness on a 4-Point Likert Scale (0-3)
4. Patient’s Global Assessment of Response to Therapy (PGA) on a 5-
point Likert Scale (0-4)
5. Investigator’s Global Assessment of Response to Therapy (IGA) on
a 5-point Likert Scale (0-4)
6. 50-Foot Walk Test (in Seconds)
 		 At baseline,2nd,4th,6th wk 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the improvement in quality of life in patient with osteoarthritis.  Baseline ,2nd,4th,6th wk 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Outcome of the study will be publish in the form of thesis. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Osteoarthritis (OA) is a chronic degenerative disorder of unknown cause characterized by gradual loss of hyaline articular cartilage.It is the second most common rheumatologic problem and the most common joint disease with a prevalence of 22-39% in India. OA is more common in women than men. It has been reported in many studies that women have more multiple joint involvement than men as well as higher prevalence and severity of osteoarthritis of hands, knees, ankles and feet. In India, women especially menopausal women with age of 46 years are at early risk of osteoarthritis. Knee is the most common joint affected by osteoarthritis.In the classical Unani literature, the illness of joints pain mentioned under the caption of “Waja‘ al-Mafāṣil”, which includes, other types of arthritis also. The term Waja‘ means pain and “Mafᾱṣil” means joints, hence “Waja‘ al-Mafāṣil” means pain in joints. Waja‘ al-Mafāṣil is also known as Gathiya (ArzānÄ«, 1931; 3 MajÅ«sÄ«, 2010) and this is one of the hereditary diseases (Ibn SÄ«nā, 2007). NSAIDs (Non-steroidal Anti-Inflammatory Drugs) are widely used in the symptomatic management of OA and other Rheumatic diseases. NSAIDs have property of blocking production of Prostaglandins (PGs). This is accomplished by inhibiting the activity of the enzyme PGG/H synthase, also called cyclooxygenase (COX). COX occurs in two isoforms, COX-1 and COX-2, which have different biological functions. Inhibition of COX-2 by NSAIDS blocks PG production at sites of inflammation or other forms of tissue damage, while inhibition of COX-1 in certain other tissues- most importantly platelets and the gastroduodenal mucosa can lead to common adverse effects of NSAIDS such as bleeding and gastrointestinal ulceration.(13) Hence, we cannot use the NSAIDs for long period because they have so many adverse effects. So, there is a need to search for alternate drugs that have less adverse effects. There are so many single as well as compound Unani formulations mentioned in classical Unani texts, which have been used in the treatment of Waja‘al-Mafāṣil by Unani Physicians since ages, but they need to be evaluated on scientific parameters in order to generate data regarding their safety and efficacy. Therefore, it has been planned to conduct the present clinical study titled “A Prospective, Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of Habb-i Dard-i Mafasil in Waja‘ alMafāṣil (Osteoarthritis)” 
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