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CTRI Number  CTRI/2024/07/070640 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating the safety and efficacy of a combination of oral and topical Unani formulations in Waja‘ al-MafāsÌ£il (Osteoarthritis Knee) 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a combination of oral and topical Unani Formulations in the Management of Waja‘ al-MafāsÌ£il (Osteoarthritis Knee)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Atiya Begum 
Designation  PG Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad.

Hyderabad
TELANGANA
500038
India 
Phone  09542805613  
Fax    
Email  dr.atiya29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Arzeena Jabeen 
Designation  Professor 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department Of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query  
Name  Atiya Begum 
Designation  Pg Scholar 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders (NRIUedMSD), Hyderabad-500038 
Address  Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  09542805613  
Fax    
Email  dr.atiya29@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine For Skin Disorders Hyderabad 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  A G Colony Road, Opposite ESI Hospital, 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 
Dr Atiya Begum  National Research Institute of Unani Medicine for Skin Disorders  OPD and IPD of Department of Moalajat.National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA 		 9542805613

dr.atiya29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,NRIUMSD, Hyderabad  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 
Comparator Agent  1.Paracetamol-Oral 2.Diclofenac Gel-Topical  1.Tablet Paracetamol Dose: 500mg BD After meal with water Mode of Administration:Oral 2.Diclofenac Gel Dose Q.S BD Mode of Administration:Local Application  
Intervention  1.Safuf(powder)-oral 2.Roghan Gul e Aak-Topical  1.Safuf(powder) Dosage Form :Safuf(Powder) Dosage:3.5gms BD after meal with water Mode of Administration: oral Composition Of Safuf:Sibr (Aloe Barbadensis Mil.) Suranjan (Colichium luteum Baker.) Zanjabeel(Zingiber officinale Rosc.) 2.Roghan Gul e Aak Dosage Form: Liquid Dose:Q.S BD Mode Of Administration: Local application Composition:Gul e Aak Calotropis procera (Ait.) Suranjan Talkh(Colichium luteum Baker) Zanjabeel(Zingiber officinale Rosc.) Ajawain e Khurasani(Hyosyamus niger Linn.) Roghan e Kunjad(Seasamum indicum)  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of any sex aged between 40to 65years
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
ii. Morning Stiffness lasting ≤30 minutes
iii. Crepitus on Active Knee Motion
3.Knee OA of Kellgren-Lawrence Grade 1 to 3
4.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF
 
 
ExclusionCriteria 
Details  1.Knee OA of Kellgren-Lawrence grade IV
2. Secondary OA, Inflammatory joint diseases (e.g. RA, psoriatic arthritis, gout), or any other type of arthritis
3.Patients on long-term steroid treatment
4.H/o having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month
5.Pregnant or Lactating Women
6.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
7.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies 
 
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.Reduction in Pain by Using VAS
2.Reduction in WOMAC Scores from baseline 		 42 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Joint Tenderness On a 4 Point Likert Scale
2.50 Foot Walk Test  		 42 Days 
 
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/ Phase 3 
Date of First Enrollment (India)   15/09/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   osteoarthritis also known as degenerative joint disease is the most common form of chronic disorders of synovial joints.  In India, Knee osteoarthritis affects 28.7% population especially, females (31.6%). OA of Knee is the major healthcare issues in an ever ageing population . confers major disability and compromised quality of life. in Unani System Of Medicine the great unani physicians detailed description in his treatise regarding the disease under the term Waja’al-Mafasil. Current pharmacological treatment are often ineffective or come with risky side effects like those from NSAIDs. There is urgent need to explore safe and effective herbal formulatons.in this regard, this Randomized ,Open Label, Active Control study is designed to evaluate the safety and efficacy of Safuf and Roghan Gul e Aak in the management of waja’al-Mafasil (osteoarthritis Knee). 
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