| CTRI Number |
CTRI/2025/11/097477 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the Causes and Symptoms of Indigestion (Amlapitta) and the Relief Provided by Jeerakadya Ghrita |
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Scientific Title of Study
|
Assessment of Annavaha Srotodushti Hetu and Lakshana in Amlapitta and Upashayatmak effect of Jeerakadya Ghrita: A Single Arm Open Label 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 Pakhrani Priyanka Mohanlal |
| Designation |
MD Scholar,Department of Roga Nidana Evam Vikriti Vigyana |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.311, 3rd floor, Academic Block,Block C, Department of Roga Nidana
Evam Vikriti Vigyana , All India Institute Of Ayurveda, Gautampuri, Sarita
Vihar, Mathura Road New Delhi
South DELHI 110076 India |
| Phone |
7972381283 |
| Fax |
|
| Email |
ppakhrani2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vivek Agarwal |
| Designation |
Additional Professor and HOD (Department of Roga Nidana Evam Vikriti Vigyana) |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.311, 3rd floor, Academic Block,Block C, Department of Roga Nidana
Evam Vikriti Vigyana , All India Institute Of Ayurveda, Gautampuri, Sarita
Vihar, Mathura Road New Delhi
South DELHI 110076 India |
| Phone |
9416608598 |
| Fax |
|
| Email |
drvivek91@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pakhrani Priyanka Mohanlal |
| Designation |
MD Scholar,Department of Roga Nidana Evam Vikriti Vigyana |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.311, 3rd floor, Academic Block,Block C, Department of Roga Nidana
Evam Vikriti Vigyana , All India Institute Of Ayurveda, Gautampuri, Sarita
Vihar, Mathura Road New Delhi
South DELHI 110076 India |
| Phone |
7972381283 |
| Fax |
|
| Email |
ppakhrani2@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri, Sarita vihar, Mathura
road, New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pakhrani Priyanka Mohanlal |
All India Institute of Ayurveda |
Room No.311, 3rd floor, Academic Block,Block C, Department of Roga Nidana
Evam Vikriti Vigyana , All India Institute Of Ayurveda, Gautampuri, Sarita
Vihar, Mathura Road New Delhi
South DELHI |
7972381283
ppakhrani2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jeerakadya Ghrita, Reference: Chakradatt, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jal), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed Amlapitta patients (based on Ayurvedic signs and symptoms like Avipaka, Klama, Utklesha, Amla-tikta udgara, Gaurava, Hrit-kantha daaha, Aruchi) attending O.P.D of AIIA
2.Willing to provide informed consent and follow study protocol.
3.Patients with deranged Annavaha srotas functions as assessed through Annavaha Srotodushti Hetu and Lakshan Questionnaire.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women.
2.History of infections or GI conditions (e.g., hepatitis, HIV, peptic ulcer, esophageal varices).
3.Substance abuse (alcohol, tobacco, or drugs).
4.Ongoing hormonal or psychosomatic treatment.
5.Patients with poor dental health.
6.Patients with controlled Diabetes mellitus, Hypertension, cardiovascular, neurological disorders, malignancies, hemorrhoids, thyroid disorders.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita.
2. Change in salivary pH from baseline to post-treatment, indicating the effect of therapy. |
1.Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in pepsinogen levels at 30th day of intervention to assess symptom relief |
0th & 30th day |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
05/01/2026 |
| 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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
“Bala Arogya Ayuscha Pranascha Agnou Pratistitha.”[1] according to Acharya Charaka, the power of Agni, or normal condition of Agni, is responsible for proper health, longevity, and vital breath. Acharya Vagbhata says that Roga Sarveapi Mandagnou.[2] Mandagni is the primary cause of all diseases. So, Agni plays a crucial role in understanding the development of illness, diagnosis, and therapy protocols. In the modern era, Amlapitta is the one of the most prevalent disease conditions of Annavaha Strotas. Ayurveda says that Pitta is of 2 types Prakrita and Vaikrita. In this condition, Pitta becomes Vaikrita or Vidagdha because the Amlaguna of Pachaka Pitta increases due to their similarity. [3] Amlapitta is one of the commonest Annavaha Srotasvyadhi, caused by vitiation of three Doshas, specifically Pachaka pitta, Samana vata, Kledaka kapha. When excessive intake of Virudha, Dushta, Amla, Vidhahi, Pitta prakopaka ahaar is consumed it causes Mandagni that leads to Vidagdhajeerna manifesting as Amlapitta in Amashaya, with the lakshanas as avipaka, klama, uthklesha, amlaudgara, daha, aruchi [4] etc. The Annavaha srotas is the one that bears a direct impact of all the dietetic errors that a person indulges.[5] Most of the gastrointestinal disorders are owing to results from abnormal functioning of agni, faulty diets like, pungent, spicy food, irregular meals pattern, habits like smoking, alcohol consumption, and psychological stress. NEED OF STUDY
• Amlapitta is a prevalent gastrointestinal disorder in Ayurvedic practice, often comparable to GERD in modern medicine. The Annavaha Srotas, responsible for the transportation and digestion of food, play a crucial role in its pathogenesis. Despite classical references to Srotodushti Hetu (pathogenic factors) and Lakshana (clinical features), there is a lack of systematic clinical correlation and scientific validation of these concepts in the context of Amlapitta. A focused study is needed to elucidate the role of Annavaha Srotas dushti in the etiopathogenesis of Amlapitta, which may enhance diagnostic accuracy & therapeutic efficacy. AIM AND OBJECTIVES- OBSERVATIONAL STUDY AIM : To evaluate the involvement of Annavaha strotdushti Hetu and Lakshana in Amlapitta. Primary Objective- • To study the pathological role of Annavaha Strotas in Amlapitta through Annavaha Srotas Hetu & Lakshana assessment questionnaire. Secondary Objective- • To analyze the relationship of salivary pH with the Amlapitta symptoms. INTERVENTIONAL STUDY: AIM- To assess the Upashayatmak effect of Jeerakadya ghrita in Amlapitta. Primary Objective- • To evaluate the Upashayatmak effect of Jeerakadya ghrita in the management of Amlapitta with reference to Amlapitta Symptom Rating Scale and increase in Salivary pH. Secondary Objective- • To assess the before and after effect of Jeerakadya Ghrit on pepsinogen 1& 2 in patients of Amlapitta. 10. OUTCOME MEASURES OBSERVATIONAL STUDY : Primary outcome: Relationship between Annavaha Strotodushti hetu and lakshana and symptoms of Amlapitta. Secondary outcome: Relationship between Salivary pH and symptoms of Amlapitta. INTERVENTIONAL STUDY : Primary outcome: 1. Improvement in clinical symptoms of Amlapitta before and after administration of Jeerakadya Ghrita. 2. Change in salivary pH from baseline to post-treatment, indicating the effect of therapy. Secondary outcome: Change in pepsinogen levels, serving as a biochemical marker to assess symptom relief.
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