Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: OLNP-06 200 mg capsule: OLNP-06 200 mg capsule should be taken twice daily orally before food for a period of 28 days.
Control Intervention1: Placebo 200 mg capsule: Placebo 200 mg caps
Sponsors
Olene Life Sciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects age 18 - 55 years. 2. Diagnosis of functional dyspepsia, Postprandial distress Syndrome by fulfilling Rome-III criteria 3. Subjects with at least one of the following two for at least 6 months i)Post prandial fullness ii)Early satiety or Subjects with two or more of the following symptoms at a moderate or severe level within the previous 03 months (At least one symptoms of postprandial fullness, upper abdominal bloating or early satiety should be included) i)Upper abdominal pain ii)Upper abdominal discomfort iii)Post Prandial fullness iv)Upper abdominal bloating v)Early satiety vi)Nausea vii)Vomiting 4. Female Subjects of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test. 5. Written informed consent signed by patient and willing to comply with the study procedure.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female patients. 2. Subject having heartburn as the most bothersome symptom or if they had moderate or severe heartburn during the baseline period. 3. History of peptic ulcer or gastro esophageal reflux disease (GERD). 4. Current prominent symptoms of irritable bowel syndrome. 5. Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy. 6. Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors and prokinetics in the preceding two weeks. 7. Participation of other clinical trials within the last 1 month. 8. Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies. 9. Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial; 10. Patient with known history of hypersensitivity to any ingredient of investigational product. Any medical condition deemed exclusionary by the Principal Investigator. 11. Subject has a history of drug and / or alcohol abuse at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Treatment efficacy (OTE)Timepoint: Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Elimination rate (score 0) of all three major symptoms Timepoint: Screening, Day 14 and Day 28;Elimination rate for each individual SymptomTimepoint: Screening, Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactSanjib Kumar Panda
Olene Life Sciences Pvt. Ltd.
Outcome results
None listed