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CTRI Number  CTRI/2010/091/000585 [Registered on: 10/11/2010]
Last Modified On: 31/07/2011
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 Effect of Unani Formulation and ibubrofen in the treatment of Osteoarthritis 
Scientific Title of Study   CLINICAL EVALUATION OF A UNANI FORMULATION IN THE TREATMENT OF OSTEOARTHRITIS WITH SPECIAL REFERENCE TO EVALUATION OF ITS ANTIOXIDANT ACTIVITY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.M.Akhtar Siddiqui 
Designation   
Affiliation   
Address  Faculty of Medicine(U)
Jamia Hamdard,Hamdard Nagar New Delhi
New Delhi
DELHI
110062
India 
Phone  01126059686,9891273627  
Fax    
Email  drmasjh@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.M.Akhtar Siddiqui 
Designation   
Affiliation   
Address  Faculty of Medicine(U)
Jamia Hamdard,Hamdard Nagar New Delhi
New Delhi
DELHI
110062
India 
Phone  01126059686,9891273627  
Fax    
Email  drmasjh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.M.Akhtar Siddiqui 
Designation   
Affiliation   
Address  Faculty of Medicine(U)
Jamia Hamdard,Hamdard Nagar New Delhi
New Delhi
DELHI
110062
India 
Phone  01126059686,9891273627  
Fax    
Email  drmasjh@rediffmail.com  
 
Source of Monetary or Material Support  
Central council for research in Unani medicine-CCRUM 
 
Primary Sponsor  
Name  Central council for research in Unani medicine-CCRUM 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Central council for research in Unani medicine-CCRUM   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mushtaq Ahmad   Majeedia Hospital ,Hamdard University,Hamdard Nagar  F/o MedicFaculty of Medicine(U),Jamia hamdard,Hamdard Nagar new Delhi,Jamia Hamdard,Hamdard Nagar -110062
New Delhi
DELHI 		 9911788213

payermushtaq@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Jamia Hamdard  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ibuprofen   400mg Thrice daily 
Intervention  Unani Formulation  Tablets (UNIM-301) Orally Twice Daily. Oil (UNIM-304) Used For Local Application UNIM-302(Pashoya) Used For Hot Fomentation On The Affected Joints 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Aged between 40 to 70 years Either Sex Patients diagnosed according to American College of Rheumatology Criteria for osteoarthritis of different joints will be selected Patients with symptoms consistent with osteoarthritis of the joint involved for at least six months prior to screening. Patients, who will be willing to discontinue all NSAIDs or other analgesic medication taken for any condition, will be included in the test group. Willingness to sign the informed consent, follow the protocol and participate in clinical trial voluntarily.  
 
ExclusionCriteria 
Details  Pregnancy and Lactation Diabetes mellitus Renal dysfunction Liver diseases Gastrointestinal diseases(Peptic ulcer disease) Other types of arthritis IHD and hypertension History of surgery of the joint involved Patients who will be unable to read/or understand the WOMAC questionnaire form  
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical Parameters WOMAC Osteoarthritis Index Visual Analogue Scale (VAS) Active Range Of Motion (AROM)   1 
 
Secondary Outcome  
Outcome  TimePoints 
hese Parameters Will Be Done Before The Treatment And After The Completion Of The Study Lipidperoxidation Reduced Glutathione Superoxide Dismutase Catalase Radiological Parameters X Rays Of The Affected Joints Will Be Taken Before And After Treatment To Compare Radiological Changes (If Any)  2 
 
Target Sample Size
Modification(s)  		 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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/08/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years=""
Months="1"
Days="26" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is randomised double blinded,single centric to assess the safety & efficacy of Unani formulation in osteoarthritis in India.The primary outcome WOMAC osteoarthritis index, Visual analogue scale (VAS),Active range of motion (AROM).Secondary outcome measuresBiochemical Parameters. These parameters will be done before the treatment and after the completion of the study ? Lipidperoxidation 27 ? Reduced glutathione 28 ? Superoxide dismutase 29 ? Catalase 30 Radiological parameters X Rays of the affected joints will be taken before and after treatment to compare radiological changes (if any)  
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