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CTRI Number  CTRI/2020/04/024715 [Registered on: 17/04/2020] Trial Registered Prospectively
Last Modified On: 11/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A clinical trial on the management of Sandhigatavata(Osteoarthritis of Knee Joint) with ketakyadi Matra Basti followed by Baladi Kwatha.  
Scientific Title of Study   An open labelled clinical trial on the management of Janu Sandhigatavata (Osteoarthritis of Knee Joint) with Ketakyadi matra Basti followed by Baladi Kwatha.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Sharma 
Designation  Pg scholar 
Affiliation  Akhand anand Ayurveda college 
Address  Opd no.11Panchakarma department, Government Akhandanand Ayurveda college, Bhadra, Ahmedabad-380001 Gujarat, India India
Opd no 11 ,Panchakarma department, Government Akhand anand Ayurveda college, Bhadra, Ahmedabad -380001 Gujarat, India
Ahmadabad
GUJARAT
380001
India 
Phone  9427332147  
Fax    
Email  poojasharma190194@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ram Shukla 
Designation  Professor 
Affiliation  Akhand anand Ayurveda college 
Address  Opd no.11 Panchakarma department, Government Akhandanand Ayurveda college, Bhadra, Ahmedabad-380001 Gujarat, India. India
Opd no.11Panchakarma department, Government Akhandanand Ayurveda college, Bhadra, Ahmedabad-380001 Gujarat, India
Ahmadabad
GUJARAT
380001
India 
Phone  9925505758  
Fax    
Email  Ram.ayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ram Shukla 
Designation  Professor 
Affiliation  Government Akhandanand Ayurveda college 
Address  Opdno.11,Panchakarma department, Government Akhandanand Ayurveda college, Bhadra, Ahmedabad-380001 Gujarat, India. India
Opd no.11,Panchakarma department, Government Akhandanand Ayurveda college, Bhadra, Ahmedabad-380001 Gujarat, India.
Ahmadabad
GUJARAT
380001
India 
Phone  9925505758  
Fax    
Email  Ram.ayu@gmail.com  
 
Source of Monetary or Material Support  
OPD and IPD of Government Akhandanand Ayurveda college and Hospital,Nr CNI church,Bhadra ,Ahmedabad- 380001.OPD and IPD of Government Smt. Maniben Hospital, Asarwa, Ahmedabad-380010.  
 
Primary Sponsor  
Name  Akhand anand Ayurveda college 
Address  Roomno11,Panchakarma department,Akhand anand Ayurveda college,Bhadra Ahmedabad.  
Type of Sponsor  Government medical college 
 
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 
Pooja Sharma  Government Akhand anand Ayurveda college  Room no 11 Panchakarma department Akhand anand Ayurveda college Ahmedabad Gujarat
Ahmadabad
GUJARAT 		 9427332147

poojasharma190194@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committe  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 
Intervention  Matra Basti followed by Baladi Kwatha  15 matra Basti will be administered to each patient Each Basti will be administered as per classical method of matra Basti followed you Baladi Kwatha for 4 weeks Drug Ketakyadi Tail Preparation method Ketakyadi Tail will be prepared as per Sharangdhar samhita Dose 60 ml Basti pradaan kala immediately after meal Subsequently patients will be given Baladi Kwatha for 4 weeks Dose 40 ml twice a day at morning and evening empty stomach (Reference Yogratnakar Uttaradha Shula nidan) 
Comparator Agent  NIL  0 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Matra Basti yogya patients having signs and symptoms of Sandhigatavata(Osteoarthritis of knee joint) with fulfilling Diagnostic criteria Duration of disease less than 10 years 
 
ExclusionCriteria 
Details  Matra Basti ayogya patients suffering from Gout Rheumatoid Arthritis Systemic Lupus Erythematous Bone TB Traumatic injuries Infective arthritis and other serious systemic disorders and duration more than 10 years will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Results will be assessed on the basis of signs and symptoms of Janu Sandhigatavata and objective criteria  45 days  
 
Secondary Outcome  
Outcome  TimePoints 
Results will be assessed on the basis of signs and symptoms of Janu Sandhigatavata and objective criteria  45 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   N/A 
Date of First Enrollment (India)   21/04/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   An open labelled clinical trial on the management of Janu Sandhigatavata (osteoarthritis of knee joint) with Ketakyadi matra Basti followed by Baladi Kwatha.  
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