Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
None listed
Sponsors
National Institute of ayurveda jaipur
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in FD symptoms in dyspepsia questionnaire.[timeframe: baseline (0-week), 4-week]Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in QOL in FD patients by , World Health Organization Quality of Life (WHO-QOL) scale [time frame: baseline (0-week), 4-week]Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactKrishna Nagar
National Institute of Ayurveda, Jaipur
Outcome results
None listed