Status:
COMPLETED
A Clinical Study to Assess the Effectiveness of ENO Lime in Participants With Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea)
Lead Sponsor:
HALEON
Conditions:
Indigestion Acid
Indigestion
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 a...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07140341
Start Date
August 20 2025
End Date
September 6 2025
Last Update
September 17 2025
Active Locations (3)
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1
Lifepoint Hospital
Pune, Maharashtra, India, 411057
2
Ojas Hospital
Pune, Maharashtra, India, 412101
3
Shri Krishna Super Speciality Institute of Ayurveda
New Delhi, India, 110058