CTRI/2023/09/058115Not yet recruitingPhase 2
Pharmaceutico Analytical Study of Avipattikara Churna and Avipattikara Suspension and their Comparative Clinical Evaluation in Amlapitta with Special Reference to Functional Dyspepsia.
ational Institute of ayurveda jaipur0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Subject fulfilling the Rome IV criteria (2016) for Functional Dyspepsia.
- •Criteria fulfilled for the last 3 months with symptom onset, at least 6 months prior to diagnosis with one or more of the following symptoms: upper abdominal pain (epigastric pain) or discomfort, postprandial fullness, early satiation, bloating, nausea and belching.
Exclusion Criteria
- •Any kind of organic lesion such as peptic ulcer, tumor of any kind, stricture, or structural deformity.
- •Subject with known history of gastric bleeding, intestinal obstruction or perforation, and previous gastrointestinal surgery.
- •? Subjects with major systemic illness including cardiac disease, diabetes, hypertension, inflammatory bowel disease etc.
- •? Patients on prolonged (=6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc., or any other drugs that may have an influence on the outcome of the study like antacids or PPI.
- •? Subjects currently taking drugs that may affect gastrointestinal motility (e.g., anticholinergic, erythromycin, azithromycin, domperidone, etc.), nonsteroidal anti-inflammatory drugs.
- •? Patients with a history of hypersensitivity to any of the trial drugs or their ingredients.
Investigators
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