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CTRI Number  CTRI/2016/03/006714 [Registered on: 07/03/2016] Trial Registered Retrospectively
Last Modified On: 29/02/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical Trial of Three Different Topical Formulations in arthritis of Knee(s) and Backache.  
Scientific Title of Study   A Randomized, Single blind, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Efficacy and Safety of Three Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s) and Backache.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No. EM/ZG-OA-BA/01/2015, Version 1, 29 April 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailesh Deshpande 
Designation  Assistant Professor  
Affiliation  PDEA’s Ayurvedic College and Sterling Hospital. 
Address  First Floor, Department of Kayachikitsa, PDEA’s Ayurvedic college and Sterling hospital, Nigadi Pradhikaran,Bhelchawk, Pune

Pune
MAHARASHTRA
400028
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Tamoli  
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society,Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Tamoli  
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society,Nayagoan, Dahisar West, Mumbai


MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Emami Ltd, Express Zone, Goregaon West, Mumbai 
 
Primary Sponsor  
Name  Emami Ltd 
Address  Express Zone, Goregaon West, Mumbai  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Deshpande  PDEA’s Ayurvedic college and hospital, Nigadi   Ground Floor, OPD No. 117, Hospital Building, Sterling Hospital, Nigadi Pradhikaran,Bhelchawk,Pune-400028
Pune
MAHARASHTRA 		 9763104451

dr.shaileshd@gmail.com 
Dr Vaishali Deshpande  Saneguruji Arogya kendra, Malwadi, Hadapsar,Pune  OPD-15,Ground Floor, Hospital Building, Saneguruji Arogya kendra, Malwadi, Hadapsar,Pune-400028
Pune
MAHARASHTRA 		 9096082950

drvaishalid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maharashtra Arogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya and Ayurved Hospital- Sane Guruji Arogya Kendra, Malwadi, Hadapsar,Pune  Approved 
Institutional Ethics Committee, PDEA’s Ayurved college and Research Centre, Nigadi.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis of Knee(s) and Backache,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AL 92  AL 92: Primary Ingredient – Diclofenac diethylamine Dosage and treatment duration: Apply sufficient quantity on index knee joint or Back twice daily for 28 days. 
Intervention  AY 94  AY 94: Peppermint (Menthol), Karpura, Yavani, Gandhapura tel, Eucalyptus oil, Sallai Guggul, Lavang tel, Rosmary oil, Sunthi, Capsaicin, Atasi ka Tel. Dosage and Treatment Duration: Apply sufficient quantity on index knee joint or Back twice daily for 28 days.  
Comparator Agent  VO 96  VO 96: Primary Ingredient – Diclofenac diethylamine Dosage and treatment duration: Apply sufficient quantity on index knee joint or Back twice daily for 28 days.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  •Pain in one or both knee joints due to OA for a minimum of six months and maximum for five years
•Low Back Pain without any serious medical/surgical condition for a minimum period of six months.
•History of knee pain or Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit
•OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s)
•Subjects not having knee or severe Lumbar joint deformity
•Subjects signing written informed consent and ready to comply with the protocol requirement
•Subjects with pain VAS greater than 40 mm on weight bearing activities
 
 
ExclusionCriteria 
Details  •Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
•Use of any analgesics except the study medication or paracetamol
•Use of systemic corticosteroids within 2 months of screening, or intraarticular viscosupplementation within the past 3 months
•Use of any other investigational drug within 1 month prior to randomization
•Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
•Known other active and serious medical or surgical disease
•Pregnancy and Lactation.
•Known hypersensitivity to ingredients used in study drug.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1). Assessment of Knee Joint Pain and Backache on VAS
2). Assessment of Knee Joint pain on WOMAC Index
3) Assessment of Back ache Bournemouth questionnaire

 		 Day 7, Day 14, Day 21, Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time of onset of action as counter irritation and in relieving painful symptoms
2. Intensity of the study drugs as a counter-irritant and in relieving painful symptoms
3. Duration of effect the study drugs as a counter irritant
4. Requirement of rescue medicines
5. Time taken to walk a distance of 50 feet
6. Global assessment for overall improvement by the investigator
7. Quality of life on SF 36 questionnaire
8. Assessment of comparative safety  		 Day 7, Day 14, Day 21, Day 28 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/09/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Done 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a Randomized, Single blind, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Efficacy and Safety of Three Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s) and Backache. The study will be carried out in two centers in India. The study will be carried out in 180 subjects (90 subjects of OA and 90 subjects of backache). Three different topical applications will be evaluated. All the subjects will be advised to apply sufficient quantity of given medication on index knee joint or Back twice daily for 28 days. The primary objectives will be to assess Knee Joint Pain and Backache on VAS, to assess Knee Joint pain on WOMAC Index and to assess Backache Bournemouth questionnaire (on day 0., day 7 , day 15 and day 28). The secondary objectives will be to assess time of onset of action (as counter irritation) and in relieving painful symptoms, Intensity of the study drugs as a counter-irritant, Intensity of the study drugs in relieving painful symptoms, Duration of effect the study drugs as a counter irritant, Requirement of rescue medicines, Time taken to walk a distance of 50 feet in the three study groups, overall relief in painful symptoms by the subject and by Investigator, overall improvement by the investigator at the end of study, Quality of life on SF -36 questionnaire, Comparative evaluation of sensorial parameters and comparative safety of study drugs (on day 0., day 7 , day 15 and day 28) 
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