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)
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Haleon
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Change from baseline in Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) symptoms using VAS scoring after 15 minutes of taking ENO Lime
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients newly experiencing symptom/s of Ajeerna vyadhi for not more than 10 days.
- •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.
- •Patients are able to read, understand, and provide written informed consent.
- •Patients who can understand and complete the VAS.
Exclusion Criteria
- •Patients with chronic and recurrent cases of Ajeerna vyadhi.
- •Patients with Updrava of Ajeerna vyadhi (Complications of indigestion).
- •Pregnant women (self-reported) and breastfeeding females or females intending to become pregnant during the study.
- •Patient had surgery in the last 14 days.
- •Patient has been exposed to barium meal 3 days before screening.
- •Patients already on any indigestion or acidity medication.
- •Patients taking any medicinal/over-the-counter (OTC)/herbal medicine from the past 3 days.
- •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.
- •Patients with known hypersensitivity to any of the components of ENO Lime (Svarjiksara [Shudh], Nimbu Rasa [Citrus limon, Fruit Juice Powder]).
- •Patients with a history of gastrointestinal (GI) disorders such as peptic ulcers, gastritis, irritable bowel syndrome (IBS), or other serious GI diseases.
Outcomes
Primary Outcomes
Change from baseline in Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) symptoms using VAS scoring after 15 minutes of taking ENO Lime
Time Frame: Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1
Secondary Outcomes
- 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)
Investigators
Dr Preeti Chhabra
Shri Krishna Super Speciality Institute of Ayurveda