| CTRI Number |
CTRI/2025/07/090153 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Assess the Effectiveness of ENO Lime powder in Participants with Symptoms of Acidity and Indigestion |
|
Scientific Title of Study
|
A multi-center, Open label, Single Arm, Interventional Clinical Study to Assess the Efficacy of ENO Lime in Patients with Ajeerna vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea) |
| 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 Preeti Chhabra |
| Designation |
Coordinating investigator |
| Affiliation |
Shri Krishna Super Speciality Institute of Ayurveda |
| Address |
C4A/48A, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
9891008498 |
| Fax |
|
| Email |
drpreeti.chh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Sharma |
| Designation |
Senior Scientist |
| Affiliation |
Haleon India |
| Address |
Haleon India, 10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon, India
Gurgaon
HARYANA
122002
India |
| Phone |
9820801694 |
| Fax |
|
| Email |
atul.x.sharma@haleon.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Sharma |
| Designation |
Senior Scientist |
| Affiliation |
Haleon India |
| Address |
Haleon India, 10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon, India
Gurgaon
HARYANA
122002
India |
| Phone |
9820801694 |
| Fax |
|
| Email |
atul.x.sharma@haleon.com |
|
|
Source of Monetary or Material Support
|
| Haleon India, 10th Floor, DLF One Horizon Center Golf Course Road, DLF Phase 5, Gurgaon (Haryana), India, 122002
|
|
|
Primary Sponsor
|
| Name |
Haleon |
| Address |
10th Floor,
DLF One Horizon Center Golf Course Road,
DLF Phase 5, Gurgaon (Haryana),
122002,
India |
| Type of Sponsor |
Other [Global Consumer Healthcare] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejas Zoal |
Lifepoint Hospital |
1, PCMC, Mumbai, Pune Bypass Rd Flyover, Near Sayaji Hotel, Shankar Kalat Nagar, Wakad, Pimpri-Chinchwad, Pune, Maharashtra, 411057
Pune
MAHARASHTRA |
02066434366
dr.tejaszoal@gmail.com |
| Dr Mahesh Kudale |
Ojas Hospital |
Bhondave, corner, DY Patil College Road, Ravet, Pune, Maharshtra,412101
Pune
MAHARASHTRA |
7385159540
maheshkudale.ojas@gmail.com |
| Dr Preeti Chhabra |
Shri Krishna Super Speciality Institute of Ayurveda |
C4A/48A, Janakpuri, New Delhi - 110058
New Delhi
DELHI |
9891008498
drpreeti.chh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Good Society for Ethics Research |
Approved |
| LPR Ethics Committee |
Approved |
| Ojas Multispeciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: AJIRNAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Eno Lime, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 1 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Consume 1 sachet of ENO Lime powder with approximately 150 milliliters of normal water as a single dose for 1 day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients newly experiencing symptom/s of Ajeerna vyadhi for not more than 10 days.
2. Patients with at least one symptom of Ajeerna vyadhi (according to Charak Samhita and Madhav Nidan) that is acidity (heartburn), acid indigestion (epigastric pain), indigestion (abdominal discomfort), or associated nausea.
3. Patients with visual analogue scale (VAS) score more than or equal to 40 millimeter (mm) and less than or equal to 80mm Ajeerna vyadhi (acidity, acid indigestion, indigestion, or associated nausea) at the Baseline visit.
4. Patients are able to read, understand, and provide written informed consent.
5. Patients who can understand and complete the VAS. |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic and recurrent cases of Ajeerna vyadhi.
2. Patients with Updrava of Ajeerna vyadhi (Complications of indigestion).
3. Pregnant women (self-reported) and breastfeeding females or females intending to become pregnant during the study.
4. Patient had surgery in the last 14 days.
5. Patient has been exposed to barium meal 3 days before screening.
6. Patients already on any indigestion or acidity medication.
7. Patients taking any medicinal/over-the-counter (OTC)/herbal medicine from the past 3 days.
8. Patients on medications that could interact with ENO Lime (example, antacids, proton pump inhibitors, or H2 blockers) as per the judgment of the Investigator/designee.
9. Patients with known hypersensitivity to any of the components of ENO Lime (Svarjiksara [Shudh], Nimbu Rasa [Citrus limon, Fruit Juice Powder]).
10. Patients with a history of gastrointestinal (GI) disorders such as peptic ulcers, gastritis, irritable bowel syndrome (IBS), or other serious GI diseases.
11. Patients with serious renal, hepatic, or cardiovascular diseases.
12. Persons on a sodium restricted diet example, those suffering from hypertension or congestive heart failure.
13. Patients who have participated in another clinical trial within the last 30 days.
14. Any patient who, in the opinion of the investigator, should not participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) symptoms using VAS scoring after 15 minutes of taking ENO Lime |
Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) symptoms using VAS scoring after 2-minutes, 1-hour, and 2-hours of taking ENO Lime |
Baseline (0 minutes pre-dose) and 2-minutes, 1-hour, 2-hours post-dose on Day 1 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
11/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This will be an open label, single arm, interventional clinical study to evaluate the efficacy and safety of ENO Lime in adult participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea). The study will be conducted at three sites in India and approximately 40 participants will be enrolled. At baseline, the participants will record the severity of symptoms of Ajeerna vyadhi using the VAS scoring before administering the ENO Lime. As per recommendation, the participants will consume the dose of the ENO Lime on-site and will record any changes in the severity of symptoms of Ajeerna vyadhi using VAS scoring at 2-minutes, 15-minutes, 1-hour, 2-hour post-dose. Participants will be permitted to take the second dose of the ENO Lime (only if required) after 2 hours of the first dose. In such cases, participants will be instructed to record symptoms of Ajeerna vyadhi again using the VAS scoring before taking the second dose (at 0 minutes) and then at 2-minutes, 15-minutes, 1-hour, and 2-hours post-second dose. |