survey to examine the acceptability of the product Vitazyme Syrup in adults including elderly to manage difficulty to digest food, pain in the stomach due to stomach discomfort, stomach fullness, reduced desire to eat

Phase 4

• Conditions: Health Condition 1: K598- Other specified functional intestinal disorders

• Registration Number: CTRI/2019/10/021821
• Lead Sponsor: East India Pharmaceutical Works Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified