Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
None listed
Sponsors
Shree Dhootapapeshwar Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either sex in the age group of 18 to 65 years. 2. Presence of Amlapitta, as diagnosed by the Amlapitta Symptom Rating Scale (ASRS) more than or equal to 5 [with Tikta Amla Udgaar (Sour and bitter belching) and Hrit Kantha Daha (Burning Sensation) Score more than or equal to 1] who have been prescribed Amlapitta Mishran Suspension. 3. Participants willing to give written informed consent. 4. Participants willing to follow up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women based on history. 2. Participants who received Amlapitta Mishran Suspension within 30 days prior to study. 3. Participants with documented H. pylori infection. 4. Participants with documented or verbal history of chronic uncontrolled disorders including hepatic, renal or endocrine diseases. 5. Participants with previous allergic reactions to any components of Amlapitta Mishran Suspension. 6. Participants with history of gastrointestinal tract malignancy. 7. Participants administered with H2 receptor antagonists (like Famotidine, and Cimetidine), muscarinic receptor antagonists (like Mebeverine, Dicyclomine, and Clidinium bromide), proton pump inhibitors (like Omeprazole, Pantoprazole, and Rabeprazole), prostaglandins (like Misoprostol) or mucosal protective agents (like Sucralfate) within 1 week prior to study. 8. Participants taking other investigational drugs within 30 days prior to the study. 9. Participants who are unable to provide informed consent, such as those suffering from mental disease, mental retardation, or unconsciousness. 10. Participants that Principal Investigator or Co-Principal Investigators consider ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Amlapitta Symptom Rating Scale (ASRS) score compared to the baseline score. The definition of "improvement" is the participants showing reduction ratio of 50 percent or more in the score.Timepoint: From baseline to day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the Postprandial Distress Syndrome (PDS) scale score compared to the baseline score 2. Change in the Epigastric Pain Syndrome (EPS) scale score compared to the baseline scoreTimepoint: From baseline to day 6 | — |
Countries
India
Contacts
Public ContactDr Mukesh B Chawda
Shree Dhootapapeshwar Limited
Outcome results
None listed