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CTRI Number  CTRI/2025/03/082365 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Panchakarma procedure in the management of hyperacidity 
Scientific Title of Study   Efficacy of Vamana Karma or Virechana Karma followed by Patoladi Kwatha and Patoladi Kwatha alone in the management of Amlapitta w.s.r. to Hyperacidity:An Open Labelled Randomized Comparative Clinical 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  Renu Moond 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  4th floor, Deptarment of Panchakarma, Institute of Teaching and Research in Ayurveda,Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  8619184958  
Fax    
Email  renumoond086@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Anup Thakar 
Designation  HOD 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no.424, 4th floor, Department of Panchakarma, Institute of Teaching and Research in Ayurveda,Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Anup Thakar 
Designation  HOD 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no.424, 4th floor, Department of Panchakarma, Institute of Teaching and Research in Ayurveda,Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Opp. B-Division police station, Gurudwara road, Jamnagar-361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda,Jamnagar 
Address  Opp. B-Division police Station, Gurudwara Road, Jamnagar, Gujarat 361008  
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 Renu Moond  PG Hospital, Institute of Teaching and AyurvedaResearch in   OPD No-12,PG Hospital, Institute of Teaching and Research in Ayurveda
Jamnagar
GUJARAT 		 8619184958

renumoond086@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda  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 ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charaka Kalpasthana-1, Procedure details: Deepana pachana with musta 4gm and shunthi 1gm BD with lukewarm water B/F for 3 to 5 days Snehpana with Goghrita for 3 to 7 days Sarvanga Abhyanaga with Bala taila f/b Bashpa Swedana after snehapana and on the day of Vamana Vamana karma for 1 day with madanaphaladi yoga Samsarjana Krama depending on Shuddhi Shamana with Patoladi kwatha for 28 days )
(1) Medicine Name: Madanaphaladi yoga, Reference: Vangasena Chikitsa sarasangraha, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: Patoladi Kwatha, Reference: Yogaratnakar Amlapitta prakaran, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 28 Days
2Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka Kalpa-1, Procedure details: Deepana pachana with musta 4gm and shunthi 1gm BD with lukewarm water B/F for 3 to 5 days Snehpana with Goghrita for 3 to 7 days Sarvanga Abhyanaga with Bala taila f/b Bashpa Swedana after snehapana for 3 days and on the day of Virechana karma Virechana Karma for 1 day with Trivrutta avaleha Samsarjana Krama depending on Shuddhi Shamana with Patoladi kwatha for 28 days)
(1) Medicine Name: Trivrutta avaleha, Reference: Ashtanaga hridaya , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: Patoladi Kwatha, Reference: Yogaratnakar amlapitta prakaran, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 28 Days
3Comparator ArmDrugClassical(1) Medicine Name: Patoladi Kwatha, Reference: Yogaratnakar Amlapitta prakaran, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient Yogya for Vamana Karma and Virechana karma
Patient presenting with cardinal sign and symptom of Amlapitta
Chronicity of disease less than 10 years 
 
ExclusionCriteria 
Details  Patient Ayogya for Vamana Karma and Virechana Karma
Age below 18 years and more than 60 years
Pregnant and lactating women
Uncontrolled D.M.,AIDS,STD,T.B. or any other serious systemic illness
Patients having symptoms due to Peptic ulcer or Duodenal ulcer
Chronicity of disease more than 10 years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that trial treatment protocol will provide relief in signs and symptoms of Amlapitta.  Group-A 45-50 days
Group-B 45-50 days
Group-C 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Appetite and bowel regulation may be improved.
Improvement in quality of life of the patient. 		 Group-A 45-50 days
Group-B 45-50 days
Group-C 45 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   01/05/2025 
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   Introduction:
Poor and inadequate dietary habits result in the imbalance and dysfunction of Annavaha strotas, leading to various disorders, one of which is Amlapitta. Acharya Vagbhata has stated that all diseases are caused by Mandagni. Which negatively affects the Samana and Udana Vayu as both Vayu are responsible for proper digestion. In the present modern era, fast hectic lifestyle, mental stress, incompatible food habits, unhealthy regimens habits like smoking, alcohols etc. Which are not suitable for the physiology of digestion and Willful medications like NSAIDS, steroids, some vitamin supplements, insufficient sleep at night, irregular meal pattern, eating to late at night, spicy, salty and sour foods, suppression of urges are causing gastric irritation and hyper gastric secretions leading to the onset of Amlapitta.

Significance:
In Western countries, hyperacidity is a common complaint. Studies indicate that up to 20-30% of adults experience symptoms of gastroesophageal reflux disease (GERD), which is closely related to hyperacidity. In developing countries, the prevalence of hyperacidity may be lower but is rising due to changes in diet and lifestyle. Urbanization and increased consumption of processed food are contributing factors. Amlapitta involve three important factor i.e. Agnimandya, Ama and Annavaha Srotodusti, Vamana is best treatment modality in Kapha vridhhi hence Vamana has been planned. As Amlapitta causes vitiation of Pitta leading to qualitative and quantitative increase of Pachaka Pitta especially in its Amla and Drava guna so Virechana has been planned to pacify the Pitta dosha in another group as comparator to treat the patients of Amlapitta. In Shamana Chikitsa, Ayurveda have mentioned the drug, which are having Tikta and Madhura-Rasa, Sheeta-Virya and Katu-Vipaka, Laghu and Ruksha guna. Hence Patoladi Kwatha will be used for pana. 

Aim & Objectives:
Aims:
To compare the efficacy of Vamana Karma or Virechana Karma followed by Patoladi Kwatha and Patoladi Kwatha alone in the management of Amlapitta. 

Objectives:
1. To assess the efficacy of Vamana Karma followed by Patoladi Kwatha in the management of Amlapitta.
2. To assess the efficacy of Virechana Karma followed by Patoladi Kwatha in the management of Amlapitta.
3. To assess the efficacy of Patoladi Kwatha alone in the management of Amlapitta.

Materials and methods:
30 Diagnosed and newly diagnosed patients of Amlapitta will be enrolled in three groups. Group A patients will receive intervention with Vamana Karma followed by Patoladi Kwatha. Group B Patients will receive Virechana Karma followed by Patoladi Kwatha. Group C Patients will receive Patoladi Kwatha.

Results and Discussion:
Data generated during the above study will be present in a systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Follow up:
After completion of therapy, follow up will be done after 15 days to assess the status of patient, where patient will be asked to report.

Adverse effects:  
This drug have no known unwanted effects. Adverse Drug Reaction if any observed will  be reported to the Pharmacovigilance cell of I.R.A Jamnagar .
 
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