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CTRI Number  CTRI/2024/07/070269 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the effectiveness of yashtyahvyadi ksheer basti for 9day in the management of vatarakta(Gout)  
Scientific Title of Study   Effectiveness of an open label single arm study with yashtyahvyadi ksheer basti as modified kala basti in vatarakta(Gout) 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Supriya Mishra 
Designation  PG student 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospitalospital 
Address  Department of Panchkarma,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M road, Thanniruhalla, Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  8210282255  
Fax    
Email  sprmishra26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lohith B A 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Panchkarma,Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital,B M road, Thanniruhalla, Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithba@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Lohith B A 
Designation  Associate professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Panchkarma,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithba@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan-573201, Karnataka, India Phone Number:08172256460 Email: sdmcah@gmail.com 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  B M Road, Thanniruhalla, Hassan-573201, Karnataka, India Phone number:08172256460 Email: sdmcah@gmail.com 
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 Supriya Mishra  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital  OPD No.5 Department of Panchkarma,
Hassan
KARNATAKA 		 08172256460

sprmishra26@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 B M road Thanniruhalla Hassan-573201, Karnataka, India,Phone number 08172256460,Email: sdmcah@gmail.com  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Poorvakarma- Abhyanga,Nadi sweda,pradhan karma -modified kala basti,pashchat karma- monitoring (Procedure Reference: Sushrut Chikitsa 35/6, Procedure details: Modified kala basti for 9day)
(1) Medicine Name: Yashtyahvyadi ksheer basti, Reference: Charaka Siddhi 3/46, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 440(ml), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient fulfilling the diagnostic criteria
2.Patient of either gender,from the age group of 18 to 60
3.Increased serum uric acid level (more than 7mg/dl in male and more than 6mg/dl in female
4.Fit for basti karma
5.Willing to sign the consent form 
 
ExclusionCriteria 
Details  1.Patient having history of other systemic diseases
2.Pateint with joint deformity and fractures
3.History of renal failure,HIV,HBsAg, Tuberculosis, Carcinoma
4.Congenital bone deformity
5.Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Signs and Symptoms of Vatarakta(Gout)will be assessed by giving suitable scoring after 9th day of basti and 18th day of follow up with kaishore guggulu 500mg BD(after food with lukewarm water)
The disease activity of the patient will be, assessed by Likert scale,Range of movement measured with Goniometer and serum uric acid level 		 18 day 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
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   Phase 2 
Date of First Enrollment (India)   20/07/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sprmishra26@gmail.com].

  6. For how long will this data be available start date provided 29-06-2024 and end date provided 20-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an  open label single arm clinical study to know the effectiveness of yashtyahvyadi ksheer basti in Vatarakta (Gout) in for 9consecutive day and follow up on 18th day with kaishore guggulu 500mg BD in 30 patient and that will be conducted in India.The primary outcome measures will be using Likert scale  for subjective parameters like Shoola ,Shotha ,Daha,Stabdhta ,sparshanasahatwa and twak lohith and objective parameter like serum uric acid and range of movements of affected joints with Goniometer  
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