A Clinical Study to Assess the Effectiveness of ENO Lime in Participants With Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea)

NCT07140341 | Completed Phase 3

• 1 other identifier: 300269
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of this study is to assess the efficacy of ENO Lime (fruit salt) in participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) at 15-minutes after administration of dose. 'Ajeerna vyadhi' is defined as a state of incomplete digestion and metabolism caused due to deranged action of Jatharagni (digestive fire), which leads to the formation of an unprocessed or under-processed state of ingested food termed as Ajeerna.

Conditions

Indigestion Acid; Indigestion; Nausea

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 15 Minutes of Taking ENO Lime

  The severity of symptoms of Ajeerna vyadhi will be recorded using VAS scoring. Participants will record a score with a mark at one point along the length of a 100-millimeter (mm) line, where the lowest score 0-mm indicates 'no discomfort' and highest score 100-mm indicates 'worst possible discomfort'. Higher the score, more severe will be the symptoms. Change from baseline will be calculated by subtracting baseline value from the value at 15-minutes.

  Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1

Secondary Outcomes (1)

• 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

Study Arms (1)

ENO Lime

EXPERIMENTAL

Participants will be instructed to take 1 sachet of ENO Lime powder with approximately 150 milliliters (ml) of normal water as a single dose. Participants will be advised to repeat the dose after 2-hours, if necessary (Maximum 2 sachet per 24-hours). Participants will be followed up for 24-hours.

Drug: ENO Lime

Interventions

ENO Lime DRUG

A fruit salt (sachet of 5-gram powder) with lime flavor containing Svarjiksara (Shudh) 2220 milligram (mg) and Nimbu Rasa (Citrus limon, Fruit Juice Powder) 150 mg

ENO Lime

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants with age 18-60 years (both inclusive).
• Participants newly experiencing symptom/s of Ajeerna vyadhi for not more than 10 days.
• Participants 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.
• Participants with VAS score greater than or equal to (\>=) 40-mm and less than or equal to (\<=) 80-mm Ajeerna vyadhi (acidity, acid indigestion, indigestion, or associated nausea) at the Baseline visit.
• Participants are able to read, understand, and provide written informed consent.
• Participants who can understand and complete the VAS.

You may not qualify if:

• Participants with chronic and recurrent cases of Ajeerna vyadhi.
• Participants with Updrava of Ajeerna vyadhi (Complications of indigestion).
• Pregnant women (self-reported) and breastfeeding females or females intending to become pregnant during the study.
• Participant had surgery in the last 14 days.
• Participant has been exposed to barium meal 3 days before screening.
• Participants already on any indigestion or acidity medication.
• Participants taking any medicinal/over-the-counter (OTC)/ herbal medicine from the past 3 days.
• Participants on medications that could interact with ENO Lime (example, antacids, proton pump inhibitors, or H2 blockers) as per the judgment of the Investigator/designee.
• Participants with known hypersensitivity to any of the components of ENO Lime (Svarjiksara \[Shudh\], Nimbu Rasa \[Citrus limon, Fruit Juice Powder\]).
• Participants with a history of gastrointestinal (GI) disorders such as peptic ulcers, gastritis, irritable bowel syndrome (IBS), or other serious GI diseases.
• Participants with serious renal, hepatic, or cardiovascular diseases.
• Participants on a sodium restricted diet example, those suffering from hypertension or congestive heart failure.
• Participants who have participated in another clinical trial within the last 30 days.
• Any participant who, in the opinion of the investigator, should not participate in the study.

Sponsors & Collaborators

• HALEON: lead

Study Sites (3)

Lifepoint Hospital

Pune, Maharashtra, 411057, India

Location

Ojas Hospital

Pune, Maharashtra, 412101, India

Location

Shri Krishna Super Speciality Institute of Ayurveda

New Delhi, 110058, India

Location

MeSH Terms

Conditions

Dyspepsia; Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: August 20, 2025
• Primary Completion: September 6, 2025
• Study Completion: September 6, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

IN (3)