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CTRI Number  CTRI/2018/03/012400 [Registered on: 07/03/2018] Trial Registered Retrospectively
Last Modified On: 27/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Arthritis pain by a Polyherbal medicine. 
Scientific Title of Study   Clinical Evaluation of Harijiwan Oil in the treatment of Sandhivata (Osteoarthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ProfDrSudarsan Behera 
Designation  Principal and H.O.D., Kayachiktsa 
Affiliation  Gopabandhu Ayurveda Mahavidyalaya, Puri 
Address  At - VIP Road, Near Jhadeswari Temple, Puri - 2, Odisha Head of Department, Kayachiktsa, Room no. 6, Gopabandhu Ayurveda Mahavidyalaya, Puri

Puri
ORISSA
752002
India 
Phone  9437199477  
Fax    
Email  prinicipalgampuri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ProfDrSudarsan Behera 
Designation  Principal and H.O.D., Kayachiktsa 
Affiliation  Gopabandhu Ayurveda Mahavidyalaya, Puri 
Address  At - VIP Road, Near Jhadeswari Temple, Puri - 2, Odisha Head of Department, Kayachikitsa (Medicine), Room no. 6, Gopabandhu Ayurveda Mahavidyalaya, Puri

Puri
ORISSA
752002
India 
Phone  9437199477  
Fax    
Email  prinicipalgampuri@gmail.com  
 
Details of Contact Person
Public Query  
Name  ProfDrSudarsan Behera 
Designation  Principal and H.O.D., Kayachiktsa 
Affiliation  Gopabandhu Ayurveda Mahavidyalaya, Puri 
Address  At - VIP Road, Near Jhadeswari Temple, Puri - 2, Odisha, Head of Department, Kayachiktsa(Medicine) , Room no. 6, Gopabandhu Ayurveda Mahavidyalaya, Puri

Puri
ORISSA
752002
India 
Phone  9437199477  
Fax    
Email  prinicipalgampuri@gmail.com  
 
Source of Monetary or Material Support  
Harijiwan Pharmacy, At - Khadagali, Plot no. 446, Holding no. 114, P.O. - Rajgangpur, Dist - Sundergarh, Odisha, India 
 
Primary Sponsor  
Name  Harijiwan Pharmacy 
Address  At - Khadagali, Plot no. 446, Holding no. 114, P.O. - Rajgangpur, Sundergarh 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
ProfDr Sudarshan Behera  Gopabandhu Ayurveda Mahavidyalaya, Puri  OPD and IPD & Room no. 6 of Kayachikitsa (Medicine) Department, At - VIP Road, Near Jhadeswari Temple, Puri - 2, Odisha
Puri
ORISSA 		 9437199477

prinicipalgampuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, GAM, Puri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  30 to 65 years patients with osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Harijiwan Oil for external application  Classical Ayurvedic Multidrug formulation for pain releif. Apply 5ml of the oil on the skin twice/ thrice daily as per severity of the case for 21 days. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All patients presenting with the clinical features of Osteoarthritis
2. Patients diagnosed to be suffering from osteoarthritis
3. Patients of Osteoarthritis who have gone for any type of treatment with or no sub optimal relief 
 
ExclusionCriteria 
Details  1. Severe and complicated case of Osteoarthritis
2. Patient not complying the Direction of the Physician.
3. Any condition which can not be rendered as a case of O.A. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in joint pain related to O.A. and free movement of the joints.  24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in swelling of the joints  14 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/06/2017 
Date of Study Completion (India) 31/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The investigators are quite sure on the efficacy of Harijiwan Oil, a polyherbal oil containing garlic, clove, karpura, castor oil, black peeper, ajwain, nutmeg , pippali, cinnamomum, nilgiri oil sunthi and Dash mool in varied proportion; in the management of O.A. basing on the outcomes of the present study .The trial drug was found effective in improving all the signs and symptoms of OA. The mean scores of pain was reduced from 2.89 to 0.89, swelling reduced from 2.74 to 0.84, stiffness reduced from 2.70 to 0.74, crepitation reduced from 2.63 to 0.79, pain during extension and flexion reduced from 2.82 to 0.89, and tenderness reduced from 2.69 to 0.96. The mean overall score reduced from 15.61 to 4.86. All the above mentioned changes were found extremely significant statistically with p<0.0001. The overall rating of the product , we got good results in 78.87% cases, Excellent result in 14.29% cases and moderate result in 7.14% cases. Therefore only mild cases of O.A. should be prescribed for oil message, but moderate and severe to chronic cases should be prescribed with oral anti-arthritic drugs for better results. 
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