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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 
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 
 
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 
 
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 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 
 
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
1Intervention ArmDrugClassical(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: -
 
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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
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 
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  

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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