NCT07140341

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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, 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 visual analogue scale (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.

Conditions

• Indigestion Acid
• Indigestion
• Nausea

Interventions

Type	Name	Description
DRUG	ENO Lime	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

Timeline

• Start date: 2025-08-20
• Primary completion: 2025-09-06
• Completion: 2025-09-06
• First posted: 2025-08-24
• Last updated: 2025-09-17

Locations

3 sites across 1 country: India