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CTRI Number  CTRI/2023/11/059678 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on Fatty Liver Disease comparing the intervention with Cauterization and Blood letting therapy 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Agnikarma and Siravyadha in Yakriddalyudara vis-a-vis Fatty liver disease 
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 Megha R 
Designation  PG Scholar 
Affiliation  Ayurveda Mahavidyalaya and Hospital, Hubballi  
Address  Room no 17, Department of PG and PhD studies in Shalya Tantra, Room No - 17, Ayurveda Mahavidyalaya and Hospital, Heggeri extension, Old Hubli, Hubballi
Heggeri extension, Old Hubli, Hubballi 580024
Dharwad
KARNATAKA
580024
India 
Phone  8951176641  
Fax  122  
Email  lodgaaasrvms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C Thyagaraja  
Designation  Professor and Head Of the Department  
Affiliation  Ayurveda Mahavidyalaya and Hospital, Hubballi  
Address  Department of PG and PhD studies in Shalya Tantra, Ayurveda Mahavidyalaya and Hospital, Hubballi
Heggeri extension, Old Hubli, Hubballi 580024
Dharwad
KARNATAKA
580024
India 
Phone  9886245072  
Fax  122  
Email  drctraja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha R 
Designation  PG Scholar 
Affiliation  Ayurveda Mahavidyalaya and Hospital, Hubballi  
Address  Room No - 17, Department of PG and PhD studies in Shalya Tantra, Ayurveda Mahavidyalaya and Hospital, Hubballi
Heggeri extension, Old Hubli, Hubballi 580024
Dharwad
KARNATAKA
580024
India 
Phone  8951176641  
Fax  122  
Email  lodgaaasrvms@gmail.com  
 
Source of Monetary or Material Support  
Ayurveda Mahavidyalaya and Hospital, Hubballi  
 
Primary Sponsor  
Name  Dr Megha R 
Address  Ayurveda Mahavidyalaya and Hospital, Hubballi  
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 Megha R  Ayurveda Mahavidyalaya and Hospital, Hubballi   Room no 17, Department of PG and PhD studies in Shalya Tantra, Ayurveda Mahavidyalaya and Hospital, Heggeri extension, Old Hubli, Hubballi
Dharwad
KARNATAKA 		 8951176641
122
lodgaaasrvms@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurveda Mahavidyalaya and Hospital Hubli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K759||Inflammatory liver disease, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita chikitsa sthana 14th chapter 16th shloka, Procedure details: Agnikarma will be done using pippali over dakshina kurpara sandhi(right anatomical snuff box), for 4 sittings with a interval of 7 days )
(1) Medicine Name: Katuki churna, Reference: Charaka samhita sutra sthana 4th chapter , Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: tds, Duration: 45 Days
2Comparator ArmProcedure-raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रà (Procedure Reference: Sushruta samhita chikitsa sthana 14th, 13thshloka, Procedure details: Siravyadha will be done at dakshina kurpara sandhi(right cubital region) with all aseptic precautions, for 4 sittings with interval of 7 days. )
(1) Medicine Name: Katuki churna, Reference: Charaka samhita sutra sthana 4th chapter , Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: tds, Duration: 45 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Sonologically diagnosed case of grade 1 and grade 2 fatty liver disease 
 
ExclusionCriteria 
Details  Uncontrolled DM and HTN, suffering with other systemic disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in ultra sonography reading and SGOT, SGPT level, Weight, reduce in Klama, Adhmana, agnimandya and hritkanta daha after 15 days of completion of 4th sitting of the procedure  At baseline, 1st week, 2nd week, 3rd week, 4th week and 6th week 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Objective criterias like USG, SGOT SGOT, Weight  At base line & After 15 days of completion of treatment i.e., on 6 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   13/11/2023 
Date of Study Completion (India) 28/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/07/2024 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Megha R & C Thyagaraja: A comparative clinical study to evaluate the efficacy of agnikarma and siravyadha in yakriddalyudara vis-à-vis fatty liver disease. International Ayurvedic Medical Journal {online} 2025 {cited May 2025}  
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [lodgaaasrvms@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 31-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
A comparative clinical study to evaluate the efficacy of Agnikarma and Siravyadha in yakkriddaludara vis-a-vis fatty liver disease. 
Subjects fulfilling subjective and objective criterias will be choosen for the study, one group consisting of 20 subjects will be treated with Agnikarma at dakshina manibandha (right anatomical snuff box) another group of 20 subjects will be treated with siravyadha at dakshina kurpara sandhi(right cubital region) for 4 sitting each with a gap of 7 days and follow up will be done after 45 days of first sitting.
After completion of the treatment, Group B that is the subjects treated with Siravyadha showed better result.
 
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