Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: OLNP-06: 100 mg OLNP-06, twice daily
Intervention2: OLNP-06: 100 mg OLNP-06, once daily for 28 days
Intervention3: OLNP-06: 100 mg OLNP-06, twice daily for 28 days
Control Intervention1
Sponsors
Olene Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - Male or female subjects aged 18 years - 55 years. - Diagnosis of functional dyspepsia (FD), including Postprandial Distress Syndrome, fulfilling the Rome-III criteria. - Presence of at least one of the following two symptoms for at least 6 months: postprandial fullness or early satiety; - or presence of two or more of the following symptoms at a moderate or severe level on Likert scale within the previous 3 months (at least one symptom of postprandial fullness, upper abdominal bloating, or early satiety): upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomiting. - Female subjects of childbearing potential willing to use effective contraception during the study and undergo pregnancy tests. - Written informed consent signed by the patient, indicating willingness to comply with the study procedure.
Exclusion criteria
Exclusion criteria: - Pregnant and lactating female patients. - Subjects having heartburn as the most bothersome symptom or moderate/severe heartburn during the baseline period. - History of peptic ulcer or gastroesophageal reflux disease (GERD). - Current prominent symptoms of irritable bowel syndrome. - Previous gastrointestinal surgery, bariatric surgery, except appendectomy and laparoscopic cholecystectomy. - Use of aspirin, non-steroidal anti-inflammatory drugs, antibiotics, H2 receptor blockers, bismuth, proton pump inhibitors, or prokinetics in the preceding two weeks. - Participation in other clinical trials within the last 1 month. - Evidence or history of clinically significant diseases or malignancies, as judged by the Investigator. - Patients with alcohol abuse, drug dependence, or neuropsychiatric disorders that are difficult to control. - Known history of hypersensitivity to any ingredient of the investigational product. - Subjects with a history of drug or alcohol abuse at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is the change in score of the global assessment of overall treatment efficacy (OTE) questionnaire from baseline to the end of 4 weeks of treatment. Subjects will complete the OTE questionnaire before supplementation on Day 1 and weekly until the study ends. Responses will be scored on a seven-point Likert scale, and the improvement rate will be calculated by combining the percentage of subjects who are extremely improved or improved.Timepoint: Day 0 Baseline Randomization Day 1 Evaluation Day Day 7 Follow-Up Visit Day 14 plus or minus 2 Follow-Up Visit Day 28 plus or minus 2 End of Study Day 42 plus or minus 2 Post-Treatment Effect Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Elimination rate score 0 of all three major symptoms postprandial fullness, upper abdominal bloating, & early satiety will be assessed at baseline & at the end of the 4-week treatment period. Elimination rate for each individual symptom upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, excessive belching, nausea, vomiting, & heartburn will be assessed daily based on subject diaries. SIBO test hydrogen breath test will be carried out at baseline & at the end of the 4-week treatment period.Timepoint: Day 0 Baseline Randomization Day 1 Evaluation Day Day 7 Follow-Up Visit Day 14 plus or minus 2 Follow-Up Visit Day 28 plus or minus 2 End of Study Day 42 plus or minus 2 Post-Treatment Effect Assessment 2 weeks after stopping the supplementation | — |
Countries
India
Contacts
Public ContactDr Rajesh P
Rajalakshmi Hospital & Research Centre
Outcome results
None listed