| CTRI Number |
CTRI/2026/01/101607 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study to Evaluate the Effects of Kunjal Kriya and Lajasattu in the Management of Hyperacidity Amlapitta |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFECT OF KUNJAL KRIYA AND LAJASATTU IN AMLAPITTA HYPERACIDITY |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Pawar |
| Designation |
PG Scholar |
| Affiliation |
Institute for ayurved studies and Research |
| Address |
Opd no 2
PG department of Swasthvritta and yoga
Institute for ayurved studies and research
Shri krishna Ayush university
Sector 8 umri road kurukshetra
Kurukshetra
Haryana
136118
India
Kurukshetra HARYANA 136118 India |
| Phone |
8149596759 |
| Fax |
|
| Email |
ravip3414@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ravi Pawar |
| Designation |
PG Scholar |
| Affiliation |
Institute for ayurved studies and Research |
| Address |
Opd no 2
PG department of Swasthvritta and yoga
Institute for ayurved studies and research
Shri krishna Ayush university
Sector 8 umri road kurukshetra
Kurukshetra
Haryana
136118
India
Kurukshetra HARYANA 136118 India |
| Phone |
8149596759 |
| Fax |
|
| Email |
ravip3414@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravi Pawar |
| Designation |
PG Scholar |
| Affiliation |
Institute for ayurved studies and Research |
| Address |
Opd no 2
PG department of Swasthvritta and yoga
Institute for ayurved studies and research
Shri krishna Ayush university
Sector 8 umri road kurukshetra
Kurukshetra
Haryana
136118
India
Kurukshetra HARYANA 136118 India |
| Phone |
8149596759 |
| Fax |
|
| Email |
ravip3414@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and research |
| Address |
Opd no 2
PG department of Swasthvritta and yoga
Institute for ayurved studies and research
Shri krishna Ayush university
Sector 8 umri road kurukshetra
Kurukshetra
Haryana
136118
India |
| 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 Shital S Mahadik |
Institute for Ayurveda Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Opd no 2
PG department of Swasthvritta and yoga
Institute for ayurved studies and research
Shri krishna Ayush university
Sector 8 umri road kurukshetra
Kurukshetra
Haryana
136118
India Kurukshetra HARYANA |
9468475757
shitalsingla@gmail.com |
|
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Details of Ethics Committee
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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:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AMLAPITTAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Kunjal Kriya Procedure - Stand near a sink, drink
at least six glasses of prepared water one after other, as quickly as possible, until it feels that stomach cannot hold any more. When stomach is full, the urge to vomit will occur automatically. Lean forward, keeping the trunk as horizontal as possible. Open the mouth and place the middle and index finger of right hand as far as possible. Gently rub and press the back of the tongue. This should induce the water to gush out from the stomach. Frequency - Patient will be adviced to perform Kunjal Kriya early in the morning empty stomach daily for 21 days. Duration - Total Duration of therapy will be 21 days, Ritucarya: N/A, Acara Rasayana:N/A, Other:N/A, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lajasattu , Reference: Bhaishjya Ratnavali Amlapitta Chikitsa Rogadhikar 56/05, Route: Oral, Dosage Form: Sattu, Dose: 30(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical symptoms of Amlapitta.
Patients of either sex and between 20-40 years of age Patients willing and able to carry out treatment for 4 weeks
Patients will be registered with duly signed informed consent prior to the trial
|
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| ExclusionCriteria |
| Details |
Patients with diagnosed cases of gastric, peptic and duodenal ulcers
Patients with any GIT abdominal complications and chronic illnes Patient taking drug such as NSAIDs which is supposed to increase acid production and gastric ulcerations
History of esophageal varices and hematemesis
Patients not willing to participate in a clinical study
Pregnant and lactating women are avoided for study |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| It will be assessed on the basis of statistical analysis applied on subjective parameter after completion of trial |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life
Safety & tolerability of Kunjal Kriya and Lajasattu |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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
|
Amlapitta (hyperacidity) is a common gastrointestinal disorder described in Ayurveda, primarily resulting from vitiation of Pitta dosha due to improper diet, lifestyle, and stress. Conventional management often provides temporary relief and may be associated with adverse effects, highlighting the need for safe and effective alternative approaches. This randomized open-label comparative clinical study was designed to assess and compare the therapeutic effects of Kunjal Kriya (a yogic cleansing practice) and Laja Sattu (a classical Ayurvedic dietary formulation) in the management of Amlapitta.
Patients diagnosed with Amlapitta were randomly allocated into two groups. One group received Kunjal Kriya as per standard yogic guidelines, while the other group was administered Laja Sattu for a specified duration. The assessment was based on subjective parameters such as heartburn, sour belching, nausea, epigastric pain, and heaviness, along with relevant objective parameters.
The study aimed to evaluate the comparative efficacy, safety, and clinical applicability of both interventions. Findings indicated that both Kunjal Kriya and Laja Sattu were effective in reducing the symptoms of Amlapitta, with variations in the degree of relief. The study concludes that these traditional, non-pharmacological approaches can play a significant role in the holistic management of Amlapitta.
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