Study on finding the effect food supplement on indigestion or upper abdominal pai
- Conditions
- Health Condition 1: null- Dyspepsia
- Registration Number
- CTRI/2016/10/007386
- Lead Sponsor
- ITC LIFE SCIENCES AND TECHNOLOGY CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
> 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.
> 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 subjectââ?¬•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.Timepoint: Day: 14 & 28
- Secondary Outcome Measures
Name Time Method Assessment of safety among the study populationTimepoint: Day: 28