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A Clinical Study to Assess the Effectiveness of ENO Lime powder in Participants with Symptoms of Acidity and Indigestion

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) - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090153
Enrollment
40
Registered
2025-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K319- Disease of stomach and duodenum, unspecified

Interventions

None listed

Sponsors

Haleon
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change from baseline in Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) symptoms using VAS scoring after 15 minutes of taking ENO LimeTimepoint: Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1

Secondary

MeasureTime frame
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 LimeTimepoint: Baseline (0 minutes pre-dose) and 2-minutes, 1-hour, 2-hours post-dose on Day 1

Countries

India

Contacts

Public ContactDr Atul Sharma

Haleon India

atul.x.sharma@haleon.com9820801694

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026