A clinical study to understand the effectiveness of a new product in adult subjects with stomach problem.

Not Applicable

Completed

• Conditions: Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis

• Registration Number: CTRI/2020/03/023910
• Lead Sponsor: Giellepi Spa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1 Patient should be able to give written informed consent.

2 Diagnosis of GERD by endoscopy

3 Males and females 18 -65 years of age (both inclusive).â?¨

4 Subjects 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).

5Subjects who are negative for Helicobacter pylori infection

6 Childbearing women using either oral or local contraceptives.

7 Ability to comply with requirements of trial

Exclusion Criteria

Subjects with esophagitis and complications of gastroesophageal reflux disease including oesophageal stricture, Barrettâ??s oesophagus or adenocarcinoma of the oesophagus

Subjects with any significant intestinal maladies (including known gastric and duodenal ulcer, hiatal hernia, infections or inflammatory conditions of the small or large intestine, and obstructions)

Subjects with dyspepsia, Malabsorption, celiac disease, prior gastric surgery, 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.

Known history of drug or alcohol abuse

Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.

Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV), cardiac disease, kidney disease, that in the opinion of the investigator could affect the efficacy and safety outcome of the study.

Patients 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, Small intestine bacterial overgrowth (SIBO), chronic pancreatitis, or cystic fibrosis, lactase deficiency, or lactose intolerance, biliary atresia, parasitic diseases, diseases of the gallbladder, liver, kidney or pancreas etc.

Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease (e.g, chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)

9.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values >= 2.5 X Upper Limit of Normal (ULN), Serum creatinine of >= 1.5 mg/dL

10.Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.

Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial.

Pregnant women.

Known hypersensitivity to, or intolerance of, study medications or their formulation excipients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified