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CTRI Number  CTRI/2019/05/019179 [Registered on: 16/05/2019] Trial Registered Prospectively
Last Modified On: 15/05/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of the efficacy and safety of PR/HC/1718/001 in knee osteoarthritis. 
Scientific Title of Study   Evaluation of the efficacy and safety of PR/HC/1718/001 in knee osteoarthritis: A randomized double-blind controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharad Dhawade 
Designation  Ayurvedic Consultant  
Affiliation  Lokmanya Medical Research Centre 
Address  Lokmanya Medical Research Centre 4th floor OPD 5, 314/B telco road, chinchwad station Chinchwad Pune 33

Pune
MAHARASHTRA
411033
India 
Phone  9922926844  
Fax    
Email  sharaddhawade123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Payal Gawali 
Designation  Manager 
Affiliation  Aayush Healthcare 
Address  D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035

Pune
MAHARASHTRA
411035
India 
Phone  7887591192  
Fax    
Email  payalgawali.aayush@gmail.com  
 
Details of Contact Person
Public Query  
Name  Payal Gawali 
Designation  Manager 
Affiliation  Aayush Healthcare 
Address  D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035

Pune
MAHARASHTRA
411035
India 
Phone  7887591192  
Fax    
Email  payalgawali.aayush@gmail.com  
 
Source of Monetary or Material Support  
Aayush Healthcare D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 
 
Primary Sponsor  
Name  Aayush Healthcare 
Address  D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 
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 
Ms Varsha Bachkar   Lokmanya Medical Research Centre   Ayurved Dept. 4th Floor, 314/B Telco Road, Chinchwad Pune 411033
Pune
MAHARASHTRA 		 8446623333

bachkarvarsha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Inert like PR/HC/1718/001 
Intervention  PR/HC/1718/001   PR/HC/1718/001 is a polyherbal formulation intended to be useful in osteoarthritis of knee. Dose of 1 gm twice daily in 500mg divided doses for 3 months  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either sex, 40 to 70 years of age.
2. Diagnosis of OA knees , based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees
3 Presence of typical osteophytes on skiagram knee is mandatory
4. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment.
5. Patient with or without receiving regular anti – inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change.
6. Willing to come for regular follow – up visits.
7. Written Informed Consent from the patient.
 
 
ExclusionCriteria 
Details  1.Patients with congenital arthropathy, rheumatoid arthritis, active
gout, other type of arthritis with/without inflammation e.g. septic ,
fibromyalgia or collagen vascular disease
2.Patients with known history of coagulopathies
3.Osteoarthritis of any other joint except knee
4.Patients with history of major trauma or surgery in the knee joint
5.Patients with uncontrolled diabetes and hypertension
6. Body mass index (BMI) >40 kg/m2.
7.Patients with any severe cardiac, renal and hepatic disease
8.Pregnant and lactating women
9.Patients who participated in any clinical trial within 30 days before
enrollment into the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment in Improvement in SF-36 Health Survey score
Assessment of patients Global Assessment, Physicians global Assessment
Assessment of performance of patient on pain VAS scale.
Local examination, clinical signs
Assessment of WOMAC
 		 Baseline to day 30, Day 60 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period.
Assessment of vitals during the study period
Assessment of inflammatory mediators CRP, IL-6, TNF-alpha 		 Baseline to day 90 
 
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)   20/05/2019 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

·  This study is a randomized double blind parallel group placebo controlled study, this study is aimed to check efficacy and tolerability of PR/HC/1718/001  in knee osteoarthritis patients of either sexes as an adjuvant treatment.

 
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