| CTRI Number |
CTRI/2026/04/107443 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Acidity with kunjal kriya and Eladi churna |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ELADI CHURNA AND KUNJAL KRIYA IN AMLAPITTA W.S.R TO HYPERACIDITY |
| Trial Acronym |
Amlapitta and Hyperacidity |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Sharma |
| Designation |
PG scholar |
| Affiliation |
Sri Ganganagar College of Ayurvedic Scienceand Hospital, Tantia university, Sriganganagar Rajasthan |
| Address |
OPD of Swasthavritta evum Yoga,Room no-9, Sri ganganagar college of ayurvedic science and Hospital, Hanumangarh road sri ganganagar Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8979695266 |
| Fax |
|
| Email |
Vaibhav.786.vs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudesh Kumar Bhambu |
| Designation |
Associate professor |
| Affiliation |
Sri ganganagar college of ayurvedic science and hospital, Tantia University, Rajasthan 335002 |
| Address |
OPD of Swasthavritta evum Yoga, Room no-9, Sri Ganganagar College of Ayurvedic Science and hospital, Tantia university, Hanumangarh road, Sri Ganganagar, Rajasthan 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
919468709698 |
| Fax |
|
| Email |
drskb07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudesh Kumar Bhambu |
| Designation |
Associate professor |
| Affiliation |
Sri ganganagar college of ayurvedic science and hospital, Tantia University, Rajasthan 335002 |
| Address |
OPD of Swasthavritta evum Yoga, Room no-9, Sri Ganganagar College of Ayurvedic Science and hospital, Tantia university, Hanumangarh road, Sri Ganganagar, Rajasthan 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
919468709698 |
| Fax |
|
| Email |
drskb07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ganganagar College of ayurvedic science and hospital, Tantia University, Hanumangarh road, Sri ganganagar (335002) |
|
|
Primary Sponsor
|
| Name |
Sri ganganagar College of ayurvedic science and hospital |
| Address |
Hanumangarh road, Sri ganganagar Rajasthan 335002 |
| Type of Sponsor |
Private 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 Rishu sharma |
Sri Ganganagar College of Ayurvedic Science and hospital |
OPD of Swasthavritta evum Yoga, Room no-9, Sri Ganganagar College of Ayurvedic Science and hospital,Hanumangarh road, Sri Ganganagar Rajasthan 335002
Ganganagar
RAJASTHAN |
9456071970
ayurvedsgnr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Faculty of Ayurveda, Tantia University, Sri Ganganagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 | Procedure | - | Kunjal kriya | (Procedure Reference: Gheranda Samhita, chapter-1, shlok-39, Procedure details: Stand upright & quickly drink about six glasses (≈2 liters) of water until the stomach is full. Lean forward, insert two fingers gently to the back of the tongue, & stimulate vomiting. Relax the body & allow water to expel naturally. Repeat until the stomach is empty. Practice Jala Neti afterward to clear mucus.)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eladi churna , Reference: Yogaratnakara, Amlapitta chikitsa adhyay, shloka-9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender and between 18-60 years of age.
2. Patients willing and able to carry out treatment for 6 weeks.
3. Patients will be registered with duly signed informed consent prior to the trail. |
|
| ExclusionCriteria |
| Details |
1. Patients with diagnosed cases of gastric, peptic and duodenal ulcers.
2. Patients with any GIT, abdominal complications and chronic illness.
3. Patients with diagnosed cases of any systemic disorder.
4.Pregnant and lactating women.
|
|
|
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 |
| The study will evaluate the clinical efficacy of Eladi churna and kunjal kriya in Amlapitta and provide scientific evidence for their role in improving Hyperacidity and quality of life |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will evaluate the clinical efficacy of Eladi churna and kunjal kriya in Amlapitta and provide scientific evidence for their role in improving Hyperacidity and symptoms such as indigestion, tiredness, nausea, vomiting, bitter and acidic vomiting. |
6 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| 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
|
Amlapitta is such type of gastrointestinal disorder which is the outcome of urbanization, changed lifestyle and dietary incompatibility. Amlapitta has become a common disease in the society affecting to adults mostly. Incidence of Gastroesophageal Reflux Disease (GERD) is found to be at least 20% in many Indian cities. It affects the quality of life and sometime though it is not life hindering but still it affects day to day life. Many studies have been done in this context but still it is a common prevalent problem and there is no permanent remedy for this. In this study, safe, effective and cheaper preventive and curative aspect of treatment will be followed to patients by using Eladi Churna and Kunjal Kriya. |