| CTRI Number |
CTRI/2026/01/101248 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study on the Benefits of a Healthy Diet Plan and Yashtimadhu Hima in Reducing Acidity Symptoms |
|
Scientific Title of Study
|
Efficacy of a structured Pathya Ahara Regimen and Yashtimadhu Hima in the Management of Amlapitta: an open labels comparative 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 |
Sagar Rahangdale |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital ,karol bagh delhi 110005 |
| Address |
PG department of Dravyaguna vigyan Ayurvedic and Unani Tibbia College and Hospital ,karol bagh delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
8806330506 |
| Fax |
|
| Email |
sagarrahangdale071@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sharma |
| Designation |
HOD and professor of Department of Dravyaguna vigyana |
| Affiliation |
ayurvedic and unani tibbia collegeand hospital ,karol bagh delhi 110005 |
| Address |
PG department of dravyaguna vigyan ayurvedic and unani tibbia collegeand hospital ,karol bagh delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Rahangdale |
| Designation |
MD Scholar |
| Affiliation |
ayurvedic and unani tibbia college and hospital ,karol bagh delhi 110005 |
| Address |
PG department of Dravyaguna Vigyan Ayurvedic and Unani Tibbia College and Hospital ,karol bagh delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
8806330506 |
| Fax |
|
| Email |
sagarrahangdale071@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and unani tibbia college and hospital |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and unani tibbia college and hospital |
| Address |
karol bagh delhi 110005 |
| Type of Sponsor |
Government medical college |
|
|
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 Sagar Rahangdale |
Ayurvedic and unani tibbia college and hospital |
OPD NO 18 PG department of dravyaguna vigyan,karol bagh,delhi
Central
DELHI |
08806330506
sagarrahangdale071@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee A and U Tibbia College and hospital Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:shali,godhuma,sattu,mudga,amaranth,bathua,parwal,dindisha,karkoti,kushmanda,kadali,dadima,dhatri,narikela jala,godugdha, Apathya:vidahi anna,viruddha aahara,amla dushta ahara,kulattha,masha,pittaprakopak ahara,madya atisevan,veg dharan,divaswapna,ratri jagrana,irregular eating habits | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Hima, Reference: Dhanwantari nighantu and Raj nighantu, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients aged 18–60 years irrespective of sex religion or caste
2 Presence of classical sign and symptoms of amlapitta
3 Duration of Amlapitta symptoms less than 6 months.
4. Patients who provide informed consent and Inclusion in Group A (Structured Pathya Ahara Regimen) or Group B (Yashtimadhu Hima) will be based on the clinical indication and suitability of the intervention for that particular patient as assessed by the investigator
|
|
| ExclusionCriteria |
| Details |
1. Known case of gastric and duodenal ulcer , gastric carcinoma.
2. Patients testing positive for Helicobacter pylori.
3. Patients with a history of cardiovascular disease or uncontrolled hypertension (systolic equal to and greater than 160 mmHg, diastolic equal to and greater than 100 mmHg despite medication), Renal impairment (Sr. creatinine greater than 1.2 mg/dl), Hepatic impairment (SGOT and SGPT greater than three times the upper limit), uncontrolled diabetes (HbA1c greater than 7.0 percent).
4. Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy etc.
5. Patient on systemic or oral steroids for more than 1 year.
6. Pregnant women and lactating mother.
7. Patients with congenital anomalies, prior major gastrointestinal surgery.
8. Patients currently under treatment for psychiatric disorders.
9. Patients who have participated in any clinical trial in the past 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the subjective parameters (classical signs and symptoms of Amlapitta example amlodgar,avipaka,aruchi) from baseline. |
1 week,2 week,3 week,4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Diet adherence (80 percent) from compliance charts.
2.Change in Quality of life in patients of amlapitta measured by WHOQOL-BREF scale.
3.Change in the laboratory safety parameters (CBC, LFT, KFT) from baseline.
|
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2026 |
| 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 Applicable |
| 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 is a commonly encountered gastrointestinal disorder described in Ayurveda, characterized by symptoms such as heartburn, sour belching, nausea, indigestion, and epigastric discomfort. Improper dietary habits, intake of incompatible food, and unhealthy lifestyle practices play a significant role in its pathogenesis. Conventional treatment often provides symptomatic relief with frequent recurrence, highlighting the need for safe and effective Ayurvedic interventions.
Ayurveda emphasizes Pathya Ahara as a primary line of management in Amlapitta. Yashtimadhu (Glycyrrhiza glabra), due to its Madhura rasa, Sheeta veerya, and Pitta-shamaka properties, is traditionally used in the management of Amlapitta, especially in the form of Hima. The present study is planned as an open-label, comparative clinical trial to evaluate the efficacy of a structured Pathya Ahara regimen and Yashtimadhu Hima in the management of Amlapitta. Eligible patients will be allotted into two separate groups. One group will receive a structured Pathya Ahara regimen, while the other group will receive Yashtimadhu Hima alone for a defined treatment period.
The efficacy of the interventions will be assessed based on improvement in subjective clinical parameters such as heartburn, sour regurgitation, nausea, indigestion, and epigastric pain. The study aims to compare the individual therapeutic effects of Pathya Ahara and Yashtimadhu Hima in the management of Amlapitta. |