CTRI/2025/08/093055 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On:
22/03/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Single Arm Study
Public Title of Study
"Studying the Impact of Vamana Therapy on People with Acid Reflux/hyperacidity (Amlapitta)"
Scientific Title of Study
To Evaluate the effect of Vaman in the management of Amla pitta.
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. Rushikesh Pravin Iche
Designation
PG Scholar
Affiliation
BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre
Address
Department of Kayachikitsa, BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda. Department of Kayachikitsa, BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda North Goa GOA 403103 India
Phone
8928460869
Fax
Email
rushikesh.p.iche128@gmail.com
Details of Contact Person Scientific Query
Name
Dr Mithun Bondre
Designation
Associate Professor
Affiliation
BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre
Address
Department of Kayachikitsa, BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda
North Goa GOA 403103 India
Phone
9823170774
Fax
Email
mithunbondre23@yahoo.co.in
Details of Contact Person Public Query
Name
Dr Mithun Bondre
Designation
Associate Professor
Affiliation
BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre
Address
Department of Kayachikitsa, BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda.
North Goa GOA 403103 India
Phone
9823170774
Fax
Email
mithunbondre23@yahoo.co.in
Source of Monetary or Material Support
BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda, Goa.pincode- 403103
Primary Sponsor
Name
Dr Rushikesh Pravin Iche
Address
Department of Kayachikitsa, BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda Goa.
Type of Sponsor
Private medical college
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 Rushikesh Pravin Iche
.BSP’s Gomantak Ayurveda Mahavidyalaya and Research Centre, Shiroda, Goa – 403103.
Department of Kayachikitsa, BSP’s Gomantaka Ayurveda Mahavidyalaya and Research Centre, Vazem, Shiroda. North Goa GOA
8928460869
rushikesh.p.iche128@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
BSP’s Gomantak Ayurveda Mahavidyalaya and Research Centre, Kamakshi Arogyadham 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,
The subjects with sign and symptoms of Amlapitta will be included. Viz.
Hruda kantha daha (burning sensation in chest & throat)
Shiroruja (headache)
Gurukosthatwa (heaviness in abdomen)
Tikta amlodgar (sour belching)
Avipaka (indigestion)
Aruchi (tastelessness)
Utklesha (nausea)
Subjects of Madhyama Koshtha only will be selected.
Age 18 – 70 years irrespective of gender.
Subjects who are willing to participate with consent.
ExclusionCriteria
Details
Diabetes Mellitus.
Known cases of tuberculosis, cancer of stomach, cancer of oesophagus, HIV, ulcerative colitis, stomach ulcers, gastro esophageal varices, intestinal tuberculosis.
Subjects less than 18 years and more than 70 years irrespective of gender.
Subjects with surgical history of GIT.
Disease of cardiac origin.
Hypertension.
Atyayik Avasthas of any disease.
Nanatmaja Vata Vyadhi.
Haemorrhagic conditions.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Observe and discover changes in signs and symptoms of amlapitta after doing the vaman procedure.
At Baseline and followup on Day 15th
Secondary Outcome
Outcome
TimePoints
It is expected that the Trial may yield a significant difference in HRQL scores in patients with Amlapitta (hyperacidity).
At baseline and follow-up on Day 15th.
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Amlapitta is a common digestive disorder in modern times, mainly caused by unhealthy lifestyle habits such as junk food, alcohol, and irregular sleep. Though not detailed by Charak, Sushruta, or Vagbhata, Kashyap Samhita describes its causes, symptoms, and involvement of Tridoshas. Other texts like Yogaratnakar, Bhavaprakash, and Madhav Nidana also mention Amlapitta, classifying it into Urdhwag and Adhog types.
Symptoms include burning sensation in the chest and throat, sour belching, constipation, body-wide burning, headache, nausea, indigestion, and lethargy. Ayurveda considers Amlapitta a Pittapradhan Tridoshaja Vyadhi, best treated with Vaman therapy.
Vaman Karma Procedure
- Purva Karma:
- Guduchi Churna for Ama Pachana
- Snehapana with Panchatikta Ghruta
- Abhyanga and Swedana with murchita tila taila
- Utkleshak Ahar (Urada Kichidi)
- Preparation of Vaman materials and emergency drugs
- Pradhana Karma:
- Conducted in Kapha Kala on an empty stomach
- Administration of milk and Nimba Patola kwatha with other herbs
- Observation of Vamana Vega and Samyaka Yoga signs
- Physical support during vomiting
- Assessment of Vamana Shuddhi
- Paschat Karma:
- Rest and hygiene post-procedure
- Haridra Dhumapana
- Avoidance of stress, exertion, and unhealthy habits
- Peyadi Samsarjana Krama for 5 days
Diet Guidelines
- Pathya: Light, oily, cool, sweet foods that aid digestion and balance doshas
- Apathya: Heavy, dry, hot, sour, and pungent foods that aggravate Pitta
This treatment aims to detoxify the body and restore digestive balance effectively.