Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Proprietary Fermented Protein 750mg + Pantaprazole 40mg: Once a day orally for 4-12 weeks of study enrollment
Control Intervention1: Pantoprazole 40mg once a day orally: Once a day oral
Sponsors
Ambtu Lifesciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients have signed an ICF before any study-specific procedures are performed. 2. Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit. 3. Patients have a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on average less than 4 days per week for less than last 4 weeks before the Screening Visit. 4. Patients have been receiving standard-labeled dose, QD, PPI therapy (treatment that, according to the Investigator s judgment, could not be further improved by changing the brand or timing of PPI administration) for leaa than 4 weeks before the Screening Visit. 5. Females of childbearing potential must have a negative urine or serum pregnancy test at the Screening Visit prior to dosing. Positive urine test results will be confirmed by a serum pregnancy test. 6. Patients agree not to make any changes to their usual diet or exercise regimen during the study 7. Patients can complete the weekly questions at least once within 14 days before the start of the Treatment Period.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GSFQ, RESQ7 and PSQITimepoint: PSQI - Baseline, Week 4, 8 & 12, GSFQ - Weekly (baseline up to 12 weeks), RESQ7 - Baseline, Week 4, 8 & 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessments - lab parameters & AETimepoint: During the study duration & at the end of treatment | — |
Countries
India
Contacts
Public ContactDr Arya
ALS
Outcome results
None listed