A study to see how safe and useful the product is for people with acidity.

An Open-Label, Single-Arm, Single-Center Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Gut Arogya in Subjects with Acidity - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099021

Enrollment

Registered

2025-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: K30- Functional dyspepsia Health Condition 2: K219- Gastro-esophageal reflux disease without esophagitis Health Condition 3: R12- Heartburn

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 to y70ears. 2. History of mild-to-moderate acidity (functional dyspepsia-like symptoms) for at least 6 months prior to screening. 3. Presence of one or more of the following symptoms within the past 7 days prior to screening: - Epigastric burning/pain - Heartburn or retrosternal burning - Bloating - Belching/eructation - Early satiety - Nausea and/or vomiting - Flatulence/gas discomfort 4. Willingness and ability to comply with all study procedures, including daily symptom diaries and study visits. 5. Signed and dated informed consent obtained prior to any study-related procedure. 6. For females of childbearing potential: agreement to use acceptable contraception throughout the study.

Exclusion criteria

Exclusion criteria: 1. Known history or current evidence of serious systemic disease, including: - Tuberculosis, HIV, HBV, or HCV infection - Ischemic heart disease, malignancy, chronic renal failure, or chronic liver disease - Jaundice or clinical evidence of active hepatitis 2. Diagnosis of other functional gastrointestinal disorders (IBS, chronic constipation, ulcer disease, GERD requiring PPI therapy). 3. Presence of diabetes mellitus or hypertension requiring daily medication. 4. Use of any investigational product within 30 days prior to enrollment. 5. Use of prohibited concomitant medications (PPIs, H2 blockers, prokinetics, antibiotics, bismuth salts, NSAIDs, herbal GI remedies) within 7 days prior to baseline. 6. Known allergy, hypersensitivity, or intolerance to any of the components of Gut Arogya. 7. Pregnant or lactating women. 8. Clinically significant laboratory abnormalities (if tested) or any other medical or psychiatric condition that, in the opinion of the Investigator, would make participation unsafe or interfere with study outcomes.

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the change from Baseline (Day 0) to End of Study (Day 30 2 days) in acidity-related symptom severity as measured by the 11-point Numeric Rating Scale (NRS; 0 = no symptom, 10 = worst imaginable) for the following symptoms: - Epigastric burning/pain - Heartburn/retrosternal burning - Bloating - Belching/eructation - Early satiety - Nausea and/or vomiting - Flatulence/gas discomfort Primary measure: - Mean change in composite symptom score (average of individual symptom NRS scores). - Change in frequency of symptomatic episodes (number of episodes in past 7 days, recorded in subject diary).Timepoint: Day 0 (Visit 1) Day 15 2 (Visit 2) Day 30 2 (Visit 3 or EOS)	—

Measure

Time frame

The primary efficacy endpoint is the change from Baseline (Day 0) to End of Study (Day 30 2 days) in acidity-related symptom severity as measured by the 11-point Numeric Rating Scale (NRS; 0 = no symptom, 10 = worst imaginable) for the following symptoms: - Epigastric burning/pain - Heartburn/retrosternal burning - Bloating - Belching/eructation - Early satiety - Nausea and/or vomiting - Flatulence/gas discomfort Primary measure: - Mean change in composite symptom score (average of individual symptom NRS scores). - Change in frequency of symptomatic episodes (number of episodes in past 7 days, recorded in subject diary).Timepoint: Day 0 (Visit 1) Day 15 2 (Visit 2) Day 30 2 (Visit 3 or EOS)

—

Secondary

Measure	Time frame
1. Quality of Life Improvement 2. Global Assessment of Tolerability 3. Safety 4. Treatment Compliance Timepoint: Day 0 (Visit 1) Day 15 2 (Visit 2) Day 30 2 (Visit 3 or EOS)	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results