Health Condition 1: null- non-erosive Gastro Esophagial Reflux Disease
Conditions
Interventions
Intervention1: Stick containing oral solution of hyaluronic acid, a mix of amino acids like proline, hydroxyl-proline, glutamine and rice extract.: 3 sticks per day.
Control Intervention1: Placebo - S
Sponsors
GIELLEPI SpA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with uncomplicated non-erosive GERD 2. Patients from both sex (males and females) 3. Patients should be at the age of above 18 years 4. Patients should have the ability to provide written informed consent 5. Patients who should be able to follow controlled diet (coffee and tea must be limited to not more than 2 cups per day. Chocolate, alcoholic beverages and spices should be reduced as much as possible).
Exclusion criteria
Exclusion criteria: 1. Patient with erosive GERD 2. Patients with severe GERD 3. Patients diagnosed with Helicobacter pylori infection 4. Patients who has inability or unwillingness to grant informed consent or to return for study visits 5. Patients with any significant intestinal maladies (including known gastric and duodenal ulcer, infections or inflammatory conditions of the small or large intestine, and obstructions). 6. Patients who undergone Gastro-intestinal surgery. 7. Patients with Malabsorption, prior gastric surgery, Barrett esophagus, esophageal stricture, pyloric stenosis, or a history of erosive esophagitis or GERD refractory to 2 months of therapy with either an H2-receptor antagonist (H2RA) or a PPI. 8. Patients with other medical conditions, including diabetes, metabolic disease, atopy, scleroderma; thyroidal disease, severe cardiovascular, renal, hepatic, pulmonary, or mental disorders; malignancy; or human immunodeficiency virus. 9. Patients with clinically relevant abnormal laboratory results at assessment, such as liver enzymes at double the upper limit of normal, were also excluded. 10. Pregnant, lactating women as well as women with positive serum pregnancy results and anyone with a history of alcohol or drug abuse within the past 5 years. 11. Suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. sub-acute obstruction, celiac disease, Crohnâ??s disease, chronic pancreatitis, or cystic fibrosis, lactase deficiency, or lactose intolerance, biliary atresia, parasitic diseases, diseases of the gallbladder, liver, or pancreas etc. 12. Subject with deteriorating health status at the time of enrollment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhea, gastro-intestinal diseases, irritable bowel syndrome) 13. Known HIV positive. (e.g., human immunodeficiency virus [HIV] infection) or any other immuno-compromised state by history 14. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 15. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values >= 2.5 X Upper Limit of Normal (ULN) 16. Serum creatinine of >= 1.5 mg/dL 17. Subject unwilling or unable to comply with the study procedures 18. History of allergy to any component of the study product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Investigational Product in terms of proportion of patients with a significant remission of non-erosive GERD symptoms.Timepoint: Day0 Day7 Day14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Investigational Product. Timepoint: Day0 Day7 Day14;To evaluate the safety and tolerability of Investigational Product. Timepoint: Day0 Day7 Day14 | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed