Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: DigeSEB Super PB: 500 mg, one capsule post meal (lunch and dinner), oral route of administration, swallow as a whole with water after having meal, for 30 days.
Control Intervention1: Pl
Sponsors
Advanced Enzymes Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects having (self-reported) dyspepsia. 2. Subject has to fill in GSRS questionnaire form (GSRS will be collected during the screening and two days prior to consent, provided the subject has reported any symptoms). The person who reports at least one or more (mild or moderate) symptoms (out of- nausea, vomiting, heartburn, abdominal pain, headache, breathless, diarrhea or constipation) at least 2 days will be included in study. 3. Subjects who have mild to moderate symptoms (for mild- 1 to 3, moderate - 4 to 6, and severe - 7 to 9). 4. Normotensive (seated, resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg). 5. Refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to visit 3 and 4. 6. Following stable and consistent diet regimen. 7. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female. 2. Subjects with BMI greater than or equal to 35 3. Subjects who are chronic smokers and alcoholics 4. Subject having known allergy to the ingredients in the test product. 5. Subject having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Gastroesophageal reflux disease (GERD), Cohns disease, short bowel, ulcerative colitis, or irritable bowel syndrome (IBS). 6. Subjects with long-standing or worsening symptoms during the run-in period. 7. Subject has a history of bariatric surgery at any time before the Screening Visit. 8. Subject has a history of any surgery in the past 3 months. 9. Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems. 10. Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening or enrollment. 11. Subject currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening or enrollment. 12. Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any digestive enzymes [prescription or over the counter (OTC)].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (to be filled daily from screening to Day30 plus or minus day 2). 2. Day 1 and Day 30 (Detailed Assessment)- VAS scale for each symptom (bloating, gas, nausea, heartburn) to be recorded at 30 min, 60 min, 90 min, and 120 min after a meal 3. Day 2 to Day 29 (Daily Assessment)- VAS scale for each symptom (bloating, gas, nausea, heartburn, etc.) to be recorded once daily at a consistent time of day (e.g. after the main meal) 4. DQLQ questionnaire (Weekly assessment from Day 1 to 30 plus or minus 2) 5. VAS for pain, stool consistency and frequency (Every day assessment from Day 1 to 30 plus or minus 2) 6. SF-36 questionnaire (Assessment on Day 1, Day 15 and Day 30 plus or minus 2) 7. Postprandial Hunger and satiety scale (Every day assessment from Day 1 to 30, 2hrs after consuming lunch)Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measure bloating or waist circumference after meal consumption (assessment at 30 min, 60 min, 90 min and 120 min after meal consumption on Day 1 and Day 30) Measure waist circumference with a measuring tape (touching skin) at umbilicus parallel to the ground around the subject. Subjects would breath normally and measurements would be taken at exhalation. Repeat measurement thrice and take average, report values in cm. 2. Microbiota analysis in an equally distributed sub population of randomly selected 8 subjects from each arm (assessment on Day 1 and Day 30). 3. Biochemical analysis in blood- a. General biochemical analysis- lipid profile, HbA1C, sugar profile, fasting Insulin b. Liver safety profile (AST, ALT, ALP, Total Albumin, Globulin, Albumin or Globulin Ratio) c. Renal safety profile (Creatinine, Blood Urea Nitrogen (BUN), Uric Acid, eGFR, Electrolytes)Timepoint: 30 days;4. Product tolerability a. Tolerability to investigation product (Questionnaire to be filled daily throughout the study duration). b. The tolerance of the product by subjects assessments for any side effect such as Nausea, Stomach upset, acute toxicity etc. observing during the study. 5. Rate of incidence of AE and SAEs - Recording any adverse or Serious adverse event (SAE) from day 01 to day 30Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Advanced Enzymes Technologies Limited
Outcome results
None listed