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Clinical Trials/CTRI/2023/09/058115
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

Sponsor
ational Institute of ayurveda jaipur

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