Health Condition 1: null- Subjects with Non Ulcer functional Dyspepsia
Conditions
Interventions
Intervention1: Asafin: 250mg of Asafin, 2 Capsules per day
Control Intervention1: Placebo: 250mg of Placebo - 2 Capsules per day
Sponsors
Akay Flavours and Aromatics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 25-55 Years ( Both Inclusive) 2. Male and Female Subjects 3. Fulfilling Rome III Diagnostic Criteria for Functional Dyspepsia 4. Subject Willing To give written Informed consent
Exclusion criteria
Exclusion criteria: 1. History of Peptic ulcer, Gastro oesophageal Reflux Disease, Gastro Intestinal surgery or any other clinically significant gastro intestinal disease. 2. Psychiatric illness 3. Pregnant or Lactating women. 4. History of Congestive Heart Failure or uncontrolled hypertension 5. Subjects with abnormal hematological or Biochemical Parameters 6. Subjects who have taken antibiotics or any other drugs in last 2 weeks whose primary site of action is in the GIT-. 7. Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in Gastrointestinal Symptom Rating Scale (GSRS), Glasgow Dyspepsia Severity Score (GDSS), and Nepean Dyspepsia Index (NDI) from BaselineTimepoint: Screening Day 0 Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative assessment of Safety parametersTimepoint: Day 0, Day 30 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Akay Flavours and Aromatics Private Limited
Outcome results
None listed