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CTRI Number  CTRI/2026/02/104489 [Registered on: 23/02/2026] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Ayurvedic Treatments- Yashtimadhu churna and Pippali madhu yoga for Acid Reflux(Urdhwag Amlpitta) 
Scientific Title of Study   A Randomized Clinical Trial to compare the efficacy of Pippali Madhu Yog with Yashtimadhu Churna In the management of Urdhwag Amlapitta. 
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 Mrunal Chandrakant Nawkar 
Designation  PG Scholar 
Affiliation  Dr Rajendra Gode Ayurveda college hospital and research center Amravati 444602 
Address  Department of Kayachikitsa room no.1 Ground floor Dr Rajendra Gode Ayurveda college hospital and research center University mardi road Amravati Maharashtra 444602 India

Amravati
MAHARASHTRA
444602
India 
Phone  08329176832  
Fax    
Email  mrunnawkar1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Mrunal Nawkar 
Designation  PG Scholor 
Affiliation  Dr Rajendra Gode Ayurveda college hospital and research center Amravati 444602 
Address  Department of Kayachikitsa room no.1 Ground floor Dr Rajendra Gode Ayurveda college hospital and research center University mardi road Amravati Maharashtra 444602 India

Amravati
MAHARASHTRA
444602
India 
Phone  8329176832  
Fax    
Email  mrunnawkar1998@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankanj Lomte  
Designation  Associate Professor 
Affiliation  Dr Rajendra Gode Ayurveda college hospital and research center Amravati 444602 
Address  Department of Kayachikitsa room no.1 Ground floor Dr Rajendra Gode Ayurveda college hospital and research center University mardi road Amravati Maharashtra 444602 India

Amravati
MAHARASHTRA
444602
India 
Phone  9970599134  
Fax    
Email  lpanks48@gmail.com  
 
Source of Monetary or Material Support  
Dr Rajendra Gode Ayurveda college hospital and research center Amravati 444602 
 
Primary Sponsor  
Name  Dr Mrunal Chandrakant Nawkar 
Address  Ganesh nagar Choti umari Akola 444005 
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 Mrunal Chandrakant Nawkar  Dr Rajendra Gode Ayurveda college hospital and research centre Amravti  Department of kayachikitsa 3rd floor Wing c Amravati 444602
Amravati
MAHARASHTRA 		 8329176832

mrunnawkar1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr.Rajendra Gode Ayu.College Amravati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Pippali madhu yoga , Reference: Dravyaguna Vidnyana, vol-II, Audbhid Aushadhi dravya , edited by Acharya priyavat Sharma , pippali, page no. 275, chaukhambha Publication, Varanasi, edition sixth- 1982. , Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Yashtimadhu churna , Reference: 8.Misra B. Bhavaprakāśa Nighaṇṭu (Indian Materia Medica). Commentary by Chunekar KC, edited by Pandey GS. Varanasi: Chaukhambha Bharati Academy; 2006. p. 62. , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Chronicity less than 1 month.
2. Patient already diagnosed with Urdhwag Amlapitta or having any two or three cardinal signs and symptoms that is HrutKanthaDaha Burning Sensation in throat and chest, Tikta Amla Udgar that is Bitter and Sour Belching of Urdhwaga Amlapitta as mentioned in classical Ayurveda text 
 
ExclusionCriteria 
Details  1.Patient having major illness like TB Malignancy, Asthma Etc.
2. Patients having gastrointestinal complication or already diagnosed with Gastric Duodenal peptic ulcers, intestinal Perforation and bleeding, Melena, CA stomach,Hiatus Hernia, Gastric ulcer, Complication of diabetes, Acute coronary syndrome, Gastric Malignancy, etc.
3. Patients having severe or projectile vomiting and loose motions.
4. Patients on any other medications like NSAIDS.
5. Pregnant and lactating mothers are excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is the change in the severity of cardinal signs and symptoms of Urdhwag Amlapitta from Day zero to the completion of the treatment Day twenty one  21 days
followup every 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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/ Phase 3 
Date of First Enrollment (India)   05/03/2026 
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 - Informed Consent Form
    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 [mrunnawkar1998@gmail.com].

  6. For how long will this data be available start date provided 05-03-2026 and end date provided 05-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is a randomized, parallel, open-label clinical trial designed to compare the efficacy of Pippali Madhu Yog and Yashtimadhu Churna in the management of Urdhwag Amlapitta, an Ayurvedic condition correlated with Gastroesophageal Reflux Disease (GERD). Urdhwag Amlapitta is characterized by symptoms such as heartburn, sour and bitter belching, throat burning, nausea, and loss of appetite, mainly due to aggravated Pitta. Modern treatments provide symptomatic relief but may cause adverse effects with long-term use, creating a need for safer alternatives.
A total of 88 patients (44 in each group), aged 25–60 years, will be selected using simple random sampling. Group A will receive Pippali Madhu Yog (250 mg BD) and Group B Yashtimadhu Churna (3 g BD) for 21 days, with follow-ups on the 7th, 14th, and 21st day. Assessment will be based on graded symptom scores and statistical analysis to determine comparative efficacy and safety of both formulations.
 
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