Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: Acineutra liquid: 10 mL of Acineutra liquid orally, twice daily, approximately 30 minutes after meals, for 7 days.
Control Intervention1: NIL: NIL
Sponsors
Virgo UAP Pharma Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female participant within age range of 18 60 years (both inclusive) 2. Patients with symptoms of hyperacidity (burning sensation, reflux, epigastric discomfort) 3. Participants able and willing to provide written informed consent, maintain participant diary and comply with the study protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Participants with severe gastrointestinal disorders or uncontrolled chronic disease (osteoarthritis, advanced cardiovascular disease, kidney failure, uncontrolled diabetes, severe COPD, terminal cancer) 2. Participants with a history of surgical interventions within the last six months 3.Participants following an abnormal or restrictive dietary pattern (e.g., low sodium, fasting, ketogenic, or high-protein diets) during the four weeks preceding enrollment or unwilling to maintain a normal, balanced diet during the study period 4. Participants with clinically significant upper gastrointestinal disorders, including hiatus hernia, peptic ulcer disease, or gastrointestinal bleeding within the past 6 months 5. Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture 6. Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test 7. Participants taking products intended for the management of acidity, reflux, indigestion, gastric protection, or related gastrointestinal symptoms, and unwilling to discontinue them for the study duration 8. Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than half pack per day 9. Participants with known hypersensitivity or allergy to any component of the investigational product 10. According to the investigator, any other illness that would interfere directly with the study results or jeopardize the participants health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate - Mean change in severity of hyperacidity-related symptoms (burning sensation, acidity, reflux) using Visual Analog Scale (VAS) Timepoint: from baseline to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Onset of Relief - Time (in minutes/hours) to first noticeable symptom relief after dosing measured via patient diary 2. Duration of Relief - Time between symptom relief and recurrence measured via patient diary 3. Frequency of Symptoms - Number of episodes/in assessment period measured via patient diary 4. Rescue Medication Use 5. Global Assessment - Patient Global Impression of Change (PGIC) Timepoint: from baseline to end of the study ;Safety Endpoint 1. Adverse events profile 2. Compliance and tolerability of the investigational productTimepoint: from baseline to end of the study | — |
Countries
India
Contacts
Public ContactHirav Jikar
Virgo UAP Pharma Private Limited
Outcome results
None listed