Health Condition 1: null- Dyspepsia
Conditions
Interventions
Intervention1: Test formulation: Herbal extract
Control Intervention1: Reference formulation: Herbal extract
Control Intervention2: Placebo: Formulation without active ingredient
Sponsors
ITC LIFE SCIENCES AND TECHNOLOGY CENTER
ITC Ltd
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline to visit 4 in dyspepsia in PP population.Timepoint: Day: 14 & 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety among the study populationTimepoint: Day: 28 | — |
Countries
India
Contacts
Public ContactVijay Bhaskar
SEMLER RESEARCH CENTER
Outcome results
None listed