| CTRI Number |
CTRI/2026/04/108056 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| 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
|
Study of Dhatri Loha in the management of Urdhvaga Amlapitta |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF DHATRI LOHA AND AVIPATTIKARA CHURNA IN THE MANAGEMENT OF URDHVAGA AMLAPITTA WITH SPECIAL REFERENCE TO GASTROESOPHAGEAL REFLUX 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 Jivan Dhansing Bibe |
| Designation |
PG Scholar |
| Affiliation |
Muniyal institute of ayurveda medical science manipal udupi |
| Address |
Outpatient department of Kayachikitsa,room no 4,ground floor,Muniyal institute of ayurveda medical science, manipal, udupi, karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8975676325 |
| Fax |
|
| Email |
jivanbibe97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shripathi Acharya G |
| Designation |
Professor and Head of department |
| Affiliation |
Muniyal institute of ayurveda medical science manipal udupi |
| Address |
Outpatient department of Kayachikitsa,room no 4,ground floor,Muniyal institute of ayurveda medical science, manipal, udupi, karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845387720 |
| Fax |
|
| Email |
shripathi_acharya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jivan Dhansing Bibe |
| Designation |
PG Scholar |
| Affiliation |
Muniyal institute of ayurveda medical science manipal udupi |
| Address |
Outpatient department of Kayachikitsa,room no 4,ground floor,Muniyal institute of ayurveda medical science, manipal, udupi, karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8975676325 |
| Fax |
|
| Email |
jivanbibe97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical science,shivalli industrial area,manipal,udupi,karnataka,india,576104 |
|
|
Primary Sponsor
|
| Name |
Dr Jivan Dhansing Bibe |
| Address |
Outpatient department of kayachikitsa,Room no 4,Ground floor,Muniyal institute of ayurveda medical science,manipal,udupi,karnataka 576104 |
| 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 Jivan Dhansing Bibe |
Muniyal institute of ayurveda medical science,manipal,udupi |
Outpatient department of Kayachikitsa,room no 4,ground floor,Muniyal institute of ayurveda medical science, manipal, udupi, karnataka 576104
Udupi
KARNATAKA |
08975676325
jivanbibe97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DHATRI LOHA, Reference: BHAISHAJYA RATNAVALI, BHARAT BHAISHAJYA RATNAKAR, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -GHRITA), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: AVIPATTIKARA CHURNA, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -LUKE WARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical signs & symptoms of Urdhvaga Amlapitta like Avipaka,Utklesha/ Hrillasa,Klama,Tikta Amlodgara,Aruchi,Gaurava,Hrit-kantha Daha.
.Patients aged between 18-60 years.Patients irrespective of Gender, Religion or occupation.
|
|
| ExclusionCriteria |
| Details |
Chronicity more than 5 years.Patient pre-diagnosed with annadrava or parinamashool.Patients pre-diagnosed with any kind of Malignancy, HIV & taking concomitant medicine proven to cause Gastritis.Pregnant & Lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the sign and symptoms of Urdhvaga Amlapitta. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reducing the classical symptoms of Urdhvaga Amlapitta like Avipaka (Indigestion),Utklesha (Nausea)/Hrillasa,Klama (Tiredness),TiktaAmloudgara (Sour and bitter belching),Aruchi (Anorexia),Gaurava (Heaviness),Hrit-kantha Daha (heart and throat burn)
|
45 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="4"
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
|
Amlapitta in Ayurveda is comparable to modern conditions such as Gastroesophageal Reflux Disease (GERD), gastritis, and acid reflux, and it is a common gastrointestinal disorder that significantly affects individuals’ wellbeing. It is mainly caused by improper diet, stress, anxiety, disturbed sleep patterns, and sedentary lifestyle habits, and if not managed properly it may become chronic and lead to complications. Ayurvedic classics explain that mental and emotional disturbances can impair digestion.Worry, grief, anger, and lack of rest weaken digestive capacity. Similarly, digestive fire (Mandagni) is the root cause of many diseases.Amlapitta has a high prevalence and is considered a lifestyle-related disorder. Individuals with a Pitta-predominant constitution may develop Amlapitta due to frequent intake of incompatible, excessively sour or spicy foods, smoking, and alcohol, which aggravate Pitta and disturb digestive balance. Although many treatment approaches exist, a definitive cure remains uncertain. The Ayurvedic formulation Dhatri Loha, described in Ayurveda classical texts, is known for its therapeutic benefits in Amlapitta. Therefore, a comparative clinical study has been planned to evaluate the efficacy of Dhatri Loha and Avipattikara Churna in the management of Urdhvaga Amlapitta with special reference to GERD. In this study, 40 patients meeting the inclusion criteria will be randomly divided into two groups: Group A (trial group) receiving Dhatri Loha tablets 500 mg twice daily just before food with Ghrita, and Group B (control group) receiving Avipattikara Churna 5 g twice daily just before food with lukewarm water,to compare effectiveness in relieving symptoms and balancing Pitta. The study intends to generate clinical evidence for safer, cost effective ayurvedic management on Urdhvaga Amlapitta |