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CTRI Number  CTRI/2019/05/019238 [Registered on: 20/05/2019] Trial Registered Prospectively
Last Modified On: 05/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study On Ayurveda Medicines-Shatyadi Kalka with Varshabhu Kashaya and Vaitarana Basti in Rheumatoid Arthritis(Amavata) 
Scientific Title of Study   A Clinical Study On The Combined Effectiveness Of Shatyadi Kalka With Varshabhu Kashaya As Anupana And Vaitarana Basti In Amavata (Rheumatoid Arthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rekha R 
Designation  Post Graduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9880094987  
Fax    
Email  drayureka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasantha B 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9880094987  
Fax    
Email  drvasanthabgowda@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Rekha R 
Designation  Post Graduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9880094987  
Fax    
Email  drayureka@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone:08172-256460 Email: college@sdmcahhassan.org  
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone:08172-256460 Email: college@sdmcahhassan.org 
Type of Sponsor  Private 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 
DR REKHA R  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital   Department of Kayachikitsa 3rd Floor,Academic Division BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone:08172-256460 Email: college@sdmcahhassan.org
Hassan
KARNATAKA 		 9880094987

drayureka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone:08172-256460 Email: research@sdmcahhassan.org  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Shatyadi kalka 12gms administered with varshabu kashaya 50ml in divided doses orally. 2.Vaitarana basti-therapeutic enema administered through rectal route as per yoga basti schedule.   1.Shatyadi kalka 12gms is administered with varshabu Kashaya 50ml as anupana orally in divided doses for 24 days. 2.Vaitarana basti-therapeutic enema as per yogabasti schedule for 8 days as mentioned below: a.Anuvasana basti with Brihatsaindhavadi Tailam 50ml administered post lunch through rectal route on 1st, 2nd,4th, 6th,8th day. b.Vaitarana basti 250ml administered post lunch post lunch through rectal route on 3rd, 5th and 7th day.  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1.Rheumatoid Arthritis Diagnosed On The Basis Of 2010 ACR EULAR Criteria.
2.Subjects Aged Between 18-70 Years.
3.Subjects Of Either Gender.
4.Subjects Who Are Fit For Bastikarma.
5.Subjects Willing To Participate In Study And Ready To Sign The Informed Consent.

Laboratory Investigations
1.Rheumatoid factor(R.A.Factor)
2.Erythrocyte sedimentation Rate(E.S.R)

 
 
ExclusionCriteria 
Details  Exclusion Criteria
1.Subjects With Known Case Of Uncontrolled Diabetes Mellitus And Essential Hypertension.
2.Subjects With Known Case Of Impaired Renal, Hepatic And Cardiac Function.
3.Pregnant And Lactating Woman.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Disease Activity Score of 28 joints

 		 24 days

 
 
Secondary Outcome  
Outcome  TimePoints 
Early morning stiffness in minutes and Erythrocyte Sedimentation Rate
 		 24 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/12/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This study is a open label, single arm, exploratory clinical study assessing the effectiveness of Shatyadi Kalka 12 gm daily with Varshabhu Kashya 50 ml daily  (in divided doses) (24 days) with therapeutic enema – Vaitarana Basti in Yoga Basti schedule for first 8 days. The study is conducted in Hospital attached to Ayurveda medical college with laboratory facilities. The primary outcome measure is disease activity score at 28 joints on 24th day and secondary outcome measure is ESR and early morning joint stiffness. 
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