| CTRI Number |
CTRI/2026/03/105246 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of an Ayurvedic Herbal Medicine on Relief of Indigestion (Hyperacidity) Symptoms in Adult Patients |
|
Scientific Title of Study
|
Evaluation of Efficacy of Polyherbal Formulation in Vidagdhajirna: A Single Arm Clinical Study. |
| 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 Bhagyashri Jayawant Patil |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune-18. |
| Address |
OPD No. 5, Kayachikitsa Department, Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8788472705 |
| Fax |
|
| Email |
patilbhagyashri0501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunvant H Yeola |
| Designation |
M. D. PhD Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune-18, |
| Address |
OPD No. 5, Kayachikitsa Department, Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Jayawant Patil |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune-18. |
| Address |
OPD No. 5, Kayachikitsa Department, Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8788472705 |
| Fax |
|
| Email |
patilbhagyashri0501@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Jayawant Patil |
| Address |
OPD NO. 5 Department of Kayachikitsa Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune. 411018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhagyashri Jayawant Patil |
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune-18. |
OPD NO. 5 Department of Kayachikitsa Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune. 411018
Pune
MAHARASHTRA |
8788472705
patilbhagyashri0501@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethics Committee Pimpri Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ayurvedic Condition- Vidagdhajirna |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Polyherbal formulation : 1. Aamalaki Ref- Priya Niganthu 2. Dhamasa Ref- Dhanwantari Niganthu 3. Yashtimadhu Ref- Kaiyyadev Niganthu 4. Parpatak Ref- Priya Niganthu , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Vidagdhajirna according to Ayurvedic classical features like Trishna (excessive thirst ), Amlodgar (sour eructation), Daha (burning sensation) will be selected. |
|
| ExclusionCriteria |
| Details |
GI disorders like duodenal ulcers, peptic ulcers, malignancy, pancreatitis, acute abdomen, hepatitis, colitis.
Pregnancy and Lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of Vidagdhajirna. |
Outcome will be assessed at baseline, 3rd day and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
16/03/2026 |
| 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 - NO
|
|
Brief Summary
|
This study aims to study the efficacy of Polyherbal Formulation on 45 patients suffering from Vidgdhajirna. 5gm churna with warm water will be administered twice a day for the duration of 7 days and with 3rd and 7th day as follow up days. Final conclusion will be drawn on the basis of statistical analysis. |