Study on finding the effect food supplement on indigestion or upper abdominal pain

Phase 2

Completed

• Conditions: Dyspepsia

• Registration Number: CTRI/2016/10/007386
• Lead Sponsor: ITC LIFE SCIENCES AND TECHNOLOGY CENTER

Brief Summary

This study will be conducted as, double blind, placebo controlled, randomized, clinical study assessing safety and efficacy of two herbal test formulations and a standard herbal reference in controlling Dyspepsia in subjects with age range between 18 to 65 years (inclusive of both the ages).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-08
• Study Completion: 2017-01-13
• Last Update Posted: 2022-10-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Male or female dyspepsia subjects aged between 18 to 65 years of age at the time of screening visit.

• Subject clinically diagnosed with dyspepsia.

• Subject must be able to understand and complete questionnaires.

• Subject must be willing to or likely to comply with all study requirements.

• Subject willing to voluntarily sign the informed consent form.

• Subject meeting all the laboratory parameters set forth to qualify to enroll in the study.

Exclusion Criteria

• Use of Proton pump inhibitors (PPIs), H2 receptor antagonists and prokinetics.

• Subjects with Acute peptic ulcer, severe GERD and/or ulcer complications.

• Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors.

• Complications of gastroesophageal reflux disease which in the opinion of the Investigator may preclude trial participation.

• Severe or unstable systemic disease/ disorder.

• Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents.

• Diagnosis of any other clinically significant medical condition or serious gastrointestinal disorder which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.

• Subjects with medical history of surgery of esophagus, stomach or duodenum.

• Abuse of drugs or alcohol confirmed by history.

• Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception.

• Subjects with deteriorating health status at the time of enrollment.

• Autoimmune diseases, recent blood donation, immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection and hepatitis B) > Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.

• Subjects unwilling or unable to comply with the study procedures.

• History of allergy to any component of the study product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline to visit 4 in dyspepsia in PP population.	Day: 14 & 28

Secondary Outcome Measures

Name	Time	Method
Assessment of safety among the study population	Day: 28

Trial Locations

Locations (1)

Bangalore Diabetes Center; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Diabetes Center

🇮🇳Bangalore, KARNATAKA, India

Dr Rajanna

Principal investigator

080-43479444

dr.rajanna@gmail.com