Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: Fenugreek galactomannans (Trigonella foenum-graecum seed extract)
Mallow (Malva sylvestris dry extract): Sachet containing 10ml oral solution to be administered 3 times a day
Control In
Sponsors
Giellepi Spa
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that Investigational product is superior to placebo and is efficacious in symptom remission (30% more symptom remission compared to placebo) in management of GERD.Timepoint: Screening day, Day 0, 7 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Safety will be assessed throughout by AE reporting, laboratory testing, PE, and vital signs. 2Change in symptom frequency and intensity using RDQ 3Change in GERD symptom assessed by VAS 4Change in Quality of life using GERD- HRQL- SF36 5Number of subjects with 50% reduction of symptoms compare to baseline 6Number of days required to achieve 24 hours without heartburn 7Fast action symptoms relief as mentioned in the RDQ 8Change in F.S.S.G 9Change in Heartburn Severity Index Timepoint: Screening day, Day 0, 7 and 14 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt Ltd
Outcome results
None listed