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CTRI Number  CTRI/2024/11/076386 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Study to evaluate the effect of Kshara basti and Churna basti in the management of Amavata 
Scientific Title of Study   A Comparative clinical study to evaluate the effect of Kshara basti and Churna basti in the management of Amavata 
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 Ravikumar M 
Designation  P G scholar 
Affiliation  Muniyal institute of Ayurveda medical sciences manipal 
Address  Muniyal institute of Ayurveda medical sciences manipal Panchakarma OPD-Room No-4 34 C Shivalli industrial area manipal

Udupi
KARNATAKA
576104
India 
Phone  9980952358  
Fax    
Email  raviamrita.kumar9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudarshana 
Designation  Professor and HOD 
Affiliation  Muniyal institute of Ayurveda medical sciences manipal 
Address  Muniyal institute of Ayurveda medical sciences manipal Panchakarma OPD Roon No - 4 34 C Shivalli industrial area manipal

Udupi
KARNATAKA
576104
India 
Phone  9481227666  
Fax    
Email  drsalevoor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravikumar M 
Designation  P G scholar 
Affiliation  Muniyal institute of Ayurveda medical sciences manipal 
Address  Muniyal institute of Ayurveda medical sciences manipal Panchakarma OPD Roon No-4 34 C Shivalli industrial area manipal

Udupi
KARNATAKA
576104
India 
Phone  9980952358  
Fax    
Email  raviamrita.kumar9@gmail.com  
 
Source of Monetary or Material Support  
Muniyal institute of Ayurveda Medical sciences Maniopal 34C Shivalli industrial area manipal Karnataka - 576104  
 
Primary Sponsor  
Name  Muniyal institute of Ayurveda 
Address  34 C Shivalli industrial area manipal, Karnataka - 576104 
Type of Sponsor  Research institution and hospital 
 
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 Ravikumar M  Muniyal institute of Ayurveda  Panchakarma OPD ground floor 34 C Shivalli industrial area Manipal
Udupi
KARNATAKA 		 9980952358

raviamrita.kumar9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Muniyal institute of Ayurveda Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Yoga basti (Procedure Reference: Chakradatta, Procedure details: kshara basti will be given in Yoga basti pattern. initially sthanika abhyanga will be given then basti is adminisered. total duration of procedure 45 min )
(1) Medicine Name: Kshara basti, Reference: chakradatta, Route: Rectal, Dosage Form: Not Applicable, Dose: 450(ml), Frequency: od, Duration: 3 Days
2Comparator ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Anuvasana basti will be given in Yoga basti pattern. initially sthanika abhyanga will be given then basti is adminisered. total duration of procedure 45 min )
(1) Medicine Name: Bhrihat saindhavadi taila, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: hs, Duration: 5 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients with classical symptoms of Amavata
patients willing to participate in the study 
 
ExclusionCriteria 
Details  patients with any uncontrolled systemic disorders. pregnant and lactating women. patients contraindicated for Basti karma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
pain and swelling  pain and swelling gets reduced by 1 week of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Swelling  Swelling gets reduced by 1 week 
 
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   N/A 
Date of First Enrollment (India)   19/11/2024 
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="25"
Months="9"
Days="23" 
Recruitment Status of Trial (Global)   Not Applicable 
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 a comparative clinical study with pre and post test design where in a 40 recruited participants will be assigned to a two groups group A  and group B with the sample size of 20 participants each suffering from amavata, will be subjected for the intervention , and the assessment will be made on 0 th day and after the completion of their treatment on the 8 th day, followed by two weeks follow up.
 
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