Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender aged 18-70 years at screening. 2. Patients diagnosed with FD according to the Rome IV Diagnostic Criteria. 3. Patients who are willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Significant medical history that could jeopardize patient safety. 2.Participation in another clinical trial. 3. Use of drugs that interfere with GI motility, except those used to treat FD. 4. History of hypersensitivity to the combination of papain and Alpha Amylase. 5. Alcoholism or smoking 6. Other GI pathologies (e.g., gastroesophageal reflux, irritable bowel syndrome). 7. Heart disease, chronic hepatic or pancreatic disease, autoimmune disorders, or genetic-metabolic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of a fixed dose combination of papain and alpha-amylase in patients with Functional Dyspepsia.Timepoint: At baseline, 1 week and 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of a fixed dose combination of papain and alpha-amylase in patients with FD.Timepoint: 14 days | — |
Countries
India
Contacts
Public ContactVikas Salgotra
Department of Clinical Research, Turacoz Healthcare Solutions
Outcome results
None listed