Health Condition 1: K598- Other specified functional intestinal disorders
Conditions
Interventions
Intervention1: Vitazyme: 1. Diastase IP (1:2000): 40 mg
(Fungal
derived from Aspergillus oryzae)
2. Cinnamon oil BP: 250 mcg
3. Cardamom oil IP: 500 mcg
4. Caraway oil IP: 500 mcg
Colourant: Caramel IP [in a non syrupy base containing
Glycerin IP & Sorbitol So
Sponsors
East India Pharmaceutical Works Limited
Eligibility
Inclusion criteria
Inclusion criteria: i. Adult subjects of both sexes between 18-65 yrs of age. ii. Presence of symptoms suggestive of indigestion, functional dyspepsia, flatulence & anorexia, such asâ??post prandial fullness, early satiety, upper abdominal (epigastric) pain/burning/discomfort, bloating & abdominal distension, excessive flatulence &/or belching, nausea, vomiting, excessive regurgitation, heartburn/reflux. iii. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: i. Pregnant or nursing women. ii. Presence of heartburn as the only predominant symptom, dysphagia or jaundice. iii. Suspected/known past history of peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), GI bleeding from any source, major GI/abdominal surgery (except appendicectomy). iv. History, suspicion or proven presence of any other organic gastroduodenal, esophageal or hepato-pancreatico-biliary lesions including esophagitis, gastric atrophy, erosive gastritis, pancreatitis, cholecystitis, cholelithiasis, etc. v. Chronic/recent use (within past 3 mths) of NSAIDs, corticosteroids or other drugs affecting gastric acid secretion or presence of chronic diseases requiring intermittent or chronic treatment with these drugs. vi. Suffering from inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) or any other form of diarrhoea (loose stools) which could be of infectious origin. vii. Suffering from any other symptoms suggestive of an ongoing infection. viii. Known allergies to any constituents of the study medications. ix. History of acute coronary syndrome, cerebrovascular events, end stage renal disease, or other serious diseases of vital organs like heart, kidney, liver, bone marrow, etc. x. History of underlying serious psychiatric illnesses or alcohol/substance abuse. xi. Patients unwilling to provide written informed consent or unlikely to comply with the trial protocol. xii. Any other condition which in the opinion of the investigator is not conducive towards inclusion of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Improved digestion & relief from dyspepsia â?? as judged by reduction in intensity &/or frequency of postprandial fullness, early satiety after the start of meals, anorexia or loss of appetite. ii. Relief from upper abdominal discomfortâ??as judged by reduction in intensity &/or frequency of epigastric pain/burning, heartburn, reflux, excessive regurgitation, bloating, abdominal distension, excessive flatulence, excessive belching/hiccups/eructation, nausea, vomiting.Timepoint: 3 Visits in a complete study | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: In case of Adverse Event unscheduled visit at any time in the study duration | — |
Countries
India
Contacts
Public ContactDr Sukumar Ghosh
East India Pharmaceutical Works Limited
Outcome results
None listed