Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
None listed
Sponsors
UMA Ayurvedic Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 55 years, male or non-pregnant female. 2. Presence of at least two (2) and not more than five (5) of the following gastrointestinal symptoms, ongoing for greater than or equals to 6 months: - Bloating - Acid reflux - Early satiety - Pain or discomfort in the upper abdomen - Burning sensation in the upper abdomen or retrosternal area - Nausea - Vomiting - Burping or flatulence 3. Symptom severity must be mild to moderate, defined as: 4. Scores of 1 or 2 on a standard 4-point Likert scale for eligible symptoms: - 0 None - 1 Mild (present but not limiting daily activity) - 2 Moderate (noticeable, affects routine mildly) - 3 Severe (interferes significantly or suggests referral need) 5. Willing to undergo gastric and fecal pH testing at baseline and study conclusion. 6. Ability and willingness to provide informed consent and adhere to the protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Participants diagnosed with any of the following: -Tuberculosis - Hepatitis B or C - HIV infection - Cancer (any type) - Chronic kidney disease - Chronic liver disease 3. History of jaundice or any current signs/symptoms suggestive of active hepatitis. 4. Participants currently diagnosed with: - Functional dyspepsia not attributed to hyperacidity - Irritable bowel syndrome (IBS) - Other functional gastrointestinal disorders based on clinical judgment 5. Use of any investigational product or trial drug within the past 30 days before screening. 6.Known diagnosis of diabetes mellitus or hypertension that requires ongoing pharmacological treatment. 7. Participants with severe gastrointestinal symptoms, defined as: - More than five (5) concurrent symptoms from the eligibility symptom list, or - Any symptom scoring 3 = Severe on the symptom Likert scale (e.g., pain/burning interfering with normal routine, severe nausea, or frequent vomiting) 8. Any abnormal laboratory findings or baseline physical findings, which in the opinion of the investigator: - May pose a risk to the participant, - Interfere with the study assessments, or - Compromise study integrity. 9. Current use of herbal medications, Ayurvedic preparations, or acid-suppressing agents (e.g., antacids, PPIs, H2 blockers) within the past 30 days. 10. History of alcohol or substance abuse within the past 24 weeks. 11. Major psychiatric illness or cognitive impairment that could affect protocol compliance, informed consent, or study follow-up. 12. Any condition or comorbidity, in the investigator s opinion, that: - Compromises the safety of the participant - Reduces the reliability of the efficacy or safety evaluation, or May require medical or surgical intervention during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative improvement in the following gastrointestinal symptoms from baseline (Visit 1) to end-of-treatment (Visit 3), measured using a standardized symptom severity score (e.g., Likert scale or symptom checklist): - Bloating - Acid reflux -Early satiety -Upper abdominal pain or discomfort -Burning sensation in the upper abdomen or retrosternal region - Nausea - Vomiting - Burping - Flatulence -Assessment time points Day 0 baseline Day 15 plus or minus 3 days Day 30 plus or minus 3 days -Change in gastric pH Mean difference in gastric pH values measured at Visit 1 Day 0 and Visit 3 Day 30 plus or minus 3 days using laboratory testing methods -Change in fecal pH Mean difference in fecal pH values between baseline and end of treatment as an indicator of gut environment Timepoint: Day 0 - Visit 1 Day 15 3 - Visit 2 Day 30 3 - Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in Quality of Life Assessed using the WHOQOL-BREF questionnaire, administered at Visit 1 and Visit 3. Domains include: - Physical health - Psychological well-being - Social relationships - Environment -Global Assessment of Efficacy A global evaluation of the overall change in symptoms, rated independently by: - The investigator, and - The participant, on a 5-point scale (e.g., Worse, No Change, Slightly Improved, Improved, Markedly Improved) -Global Assessment of Tolerability Rated by both the investigator and the participant, based on: - Adverse events (frequency, type, severity) - Clinical observations (vital signs, physical exams) - Subjective feedback on tolerabilityTimepoint: Day 0 - Visit 1 Day 15 3 - Visit 2 Day 30 3 - Visit 3 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed