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CTRI Number  CTRI/2024/02/062719 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Janu Basti and Ashvagandha Churn in the Management in Sandhigata Vata (Osteo-Arthritis) 
Scientific Title of Study   Evaluation of the Effect of Janu Basti along with Ashwagandha Churna in the management of Sandhigata Vata W.S.R. to Osteo-Arthritis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mamta Dhurve 
Designation  PG Scholar 
Affiliation  Pt Khushilal Sharma Government Ayurveda College and Institute, Bhopal 
Address  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute, Science Hills, Nehru Nagar

Bhopal
MADHYA PRADESH
462003
India 
Phone  7000855834  
Fax    
Email  mamtadhurve54@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamini Soni 
Designation  Associate Professor 
Affiliation  Pt Khushilal Sharma Government Ayurveda College and Institute, Bhopal 
Address  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute, Science Hills, Nehru Nagar

Bhopal
MADHYA PRADESH
462003
India 
Phone  8770037353  
Fax    
Email  skamini382@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mamta Dhurve 
Designation  PG Scholar 
Affiliation  Pt Khushilal Sharma Government Ayurveda College and Institute, Bhopal 
Address  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute, Science Hills, Nehru Nagar

Bhopal
MADHYA PRADESH
462003
India 
Phone  7000855834  
Fax    
Email  mamtadhurve54@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Panchakarma, Pt Khusilal Sharma Government Ayurveda College and INstitute, Bhopal 
 
Primary Sponsor  
Name  Pt Khusilal Sharma Government Ayurveda College and INstitute, Bhopal 
Address  Pt Khusilal Sharma Government Ayurveda College and INstitute, Bhopal (MP) 
Type of Sponsor  Government funding agency 
 
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 Mamta Dhurve  Pt Kshushilal Sharma Government Ayurveda College and Institute  PG Department of Panchakarma, Pt Kshushilal Sharma Government Ayurveda College and Institute, Science Hills, Nehru Nagar
Bhopal
MADHYA PRADESH 		 7000855834

mamtadhurve54@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Pt Khushilal Sharma Government Ayurveda College and Institute, Bhopal (MP)  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. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Charka Samhita, Procedure details: Janu Basti with Goghrita once a day for 21 Days)
(1) Medicine Name: Ashvagandha, Reference: DravyaGuna Vigyan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 21 Days
2Comparator Arm (Non Ayurveda)-PhysiotherapyPhysiotherapy- Hot pack (HCP) (15-20 Minute) IFT (10 to 12 Minute) once a day for 21 days
 
Inclusion Criteria  
Age From  41.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Normal BMI range will be included
2 Patients having sign and symptoms of osteoarthritis as per diagnostic criteria.
3 Those who have given written consent to participate in the study. 
 
ExclusionCriteria 
Details  1 Patients below 41 years and above 60 years.
2 Pregnant women and lactating mothers.
3 Severe Mental illness.
4 Patients who are known case of, any type of Malignancy, Chronic Renal failure, acute illness like CVA, MI, Severe Hypertension and Hormonal imbalance.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study (after 1 year) we would be able to demonstrate the effect of Janu Basti with Goghrita and Ashwagandha Churna in the management of Sandhivata (OA). It is further expected that this study would be able to provide efficacy of Janu Basti with Goghrita and Ashwagandha Churna management of Sandhivata (OA).  5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study (after 1 year) we would be able to demonstrate the effect of Janu Basti with Goghrita & Ashwagandha Churna in the management of Sandhivata (OA). It is further expected that this study would be able to provide efficacy of Janu Basti with Goghrita & Ashwagandha Churna management of Sandhivata (OA).  35th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2024 
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 Yet Recruiting 
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   It is expected that at the end of the study we would be able to demonstrate the effect of Janu Basti with Goghrita and Ashwagandha Churna in the management of Sandhivata (OA). It is further expected that this study would be able to provide efficacy of Janu Basti with Goghrita and Ashwagandha Churna management of Sandhivata (OA). 
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