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CTRI Number  CTRI/2025/06/088401 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative clinical study of Shatapaaka ksheerabala taila with Guduchi taila in vatarakta in the context of gout 
Scientific Title of Study   A comparative clinical study of shatapaaka ksheerabala taila with guduchi taila in vatarakta in the context of gout 
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 D Usha Madhuri 
Designation  Assistant professor 
Affiliation  S.V.Ayurvedic college,Tirupati 
Address  department of RVVV S.V.Ayurvedic College, tirupati

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9440867245  
Fax    
Email  atreya92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Minaz kulkarni MD, PhD 
Designation  Professor and HOD 
Affiliation  UGC 
Address  department of pancakarma Mandsaur Institute of Ayurveda Education &research,MandsaurUniversity Mandsaur

Mandsaur
MADHYA PRADESH
458001
India 
Phone  9960321732  
Fax    
Email  minaj.kulkarni@meu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr D Usha Madhuri 
Designation  Assistant professor 
Affiliation  S.V.Ayurvedic college,Tirupati 
Address  department of rvvv ,room no 28, S.V.Ayurvedic College, tirupati

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9440867245  
Fax    
Email  atreya92@gmail.com  
 
Source of Monetary or Material Support  
S.V.Ayurvedic College,Tirupati 517501 Andhrapradesh, India 
 
Primary Sponsor  
Name  dr D Usha madhuri 
Address  assistant professor, roono 28 s.v.ayurvedic college,tirupati 
Type of Sponsor  Other [self] 
 
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 D Usha Madhuri  S.V.Ayurvedic College,Tirupati  Department of RVVV,S.V.Ayurvedic College,Tirupati
Chittoor
ANDHRA PRADESH 		 9440867245

atreya92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institution ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAR, (2) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATARAKTAM, (3) ICD-10 Condition:M259||Joint disorder, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: shatapaaka ksheerabala taila, Reference: charaka samhita, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: guduchi taila, Reference: charaka samhita, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  having symptoms sandhi ruk,sandhiswayathu,sandhi raaga,sparshaasahatvam,,daaha  
 
ExclusionCriteria 
Details  pregnant and lactating mother 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
relef to the mentioned symptoms and reducing the level of uric acid  once in 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil   
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   17/06/2025 
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="1"
Days="1" 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [atreya92@gmail.com].

  6. For how long will this data be available start date provided 04-05-2025 and end date provided 03-05-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
due to sedentary lifestyle, irregular dietic habits there is increasing of prevalence of joint disorders like Vaata rakta .
if we negelect it may cause deformity which reduces our productivity ,
As satapaaka ksheerabala taila is effective in controlling both vaata and rakata according to our acharyas so i selected this one
as we know that Guduchi is best medicine in Vaatarakta to establish that how far the Shatapaaka ksheerabala is effective
 
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