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CTRI Number  CTRI/2026/01/102430 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Induppukaanam Churna in the Management of Indigestion (Functional Dyspepsia - Vishtabdha Ajeerna) 
Scientific Title of Study   Efficacy of Induppukaanam Churna in Functional Dyspepsia (Vishtabdha Ajeerna)-An Open Label Double Arm Randomized Controlled Clinical Trial 
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 Nikhil Devaraj Shringeri 
Designation  PG Scholar Department of Kayachikitsa 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka Hassan KARNATAKA 573201 India

Hassan
KARNATAKA
573201
India 
Phone  9108431680  
Fax    
Email  nikhilshringeri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yadu Gopan 
Designation  Professor Department of Kayachikitsa  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka Hassan KARNATAKA 573201 India

Hassan
KARNATAKA
573201
India 
Phone  9164543652  
Fax    
Email  vp.yadugopan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yadu Gopan 
Designation  Professor Department of Kayachikitsa  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka Hassan KARNATAKA 573201 India

Hassan
KARNATAKA
573201
India 
Phone  9164543652  
Fax    
Email  vp.yadugopan@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka 573201 India 
 
Primary Sponsor  
Name  Nikhil Devaraj Shringeri 
Address  2nd Year PG Scholar Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan 573201 Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
NIKHIL DEVARAJ SHRINGERI  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital   Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka Hassan KARNATAKA 573201 India
Hassan
KARNATAKA 		 9108431680

nikhilshringeri@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 Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: VISHTABDHAJANYA-AJIRNAM/VATAJA-AJIRNAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Induppukaanam Churna , Reference: Sahasrayoga - Churna Prakarana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Ushna jala ), Additional Information: -
2Comparator Arm (Non Ayurveda)-Pantoprazole 40mgPantoprazole 40mg is administered once a day before food with water for the period of 14 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subject diagnosed to have functional dyspepsia (Vishtabdha Ajeerna) as per the diagnostic
criteria1.
2. Subjects between age group 18 to 60 years15
3. Subjects belonging to either gender irrespective of socioeconomic status
4. Subjects willing to participate in the study and ready to sign the informed consent form 
 
ExclusionCriteria 
Details  1.Dyspepsia due to structural pathologies
2.Uncontrolled hypertension, diabetes
3.Impaired renal, hepatic and cardiac function 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Severity of Dyspepsia Assessment (SODA)  Baseline
2 Weeks
4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Symptoms of Vishtabdha Ajeerna based on WHO Scoring of Ayurveda Symptoms  Baseline
2 Weeks
4 Weeks 
 
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   Phase 1 
Date of First Enrollment (India)   01/03/2026 
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="6"
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 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 [nikhilshringeri@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2038?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The present study is an open-label double-arm randomized controlled clinical trial designed to evaluate the efficacy of Induppukaanam Churna in the management of Functional Dyspepsia (Vishtabdha Ajeerna). The formulation comprises four classical ingredients, Saindhava Lavana (Rock salt), Ajamoda (Trachyspermum ammi), Pippali (Piper longum), and Haritaki (Terminalia chebula). A total of 40 subjects diagnosed with Functional Dyspepsia per Rome IV criteria and Vishtabdha Ajeerna, aged 18–60 years, will be selected and randomly allocated into two groups of 20 each. The intervention group will receive Induppukaanam Churna (6 g twice daily before food with warm water), while the control group will receive Pantoprazole 40 mg once daily before food with water, for a duration of 14 days (with 30-day follow-up). Clinical assessment will be carried out using Severity of Dyspepsia Assessment (SODA) and WHO scoring for Ayurvedic symptoms of Vishtabdha Ajeerna at baseline, day 15, and day 30, while quality of life will be evaluated as a secondary measure. The primary objective is to compare the efficacy of Induppukaanam Churna against Pantoprazole in symptom relief; statistical analysis will be performed using repeated measures ANOVA, Friedman test, and Kruskal-Wallis test. Data will be collected in prepared case report format. Data analysis with the use of Statestical Software. 
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