Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Narikela lavan and Amlakyadi churna: 1.Narikela Lavana
Dose: 2 gram, twice daily
Dosage form: Coarse Powder
Route of administration: Oral
Time of administration: Before food
Anupana: wa
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex aged between 18 to 50 years. 2.Subject fulfilling Rome IV criteria (2016) for Functional Dyspepsia. 3.Criteria fulfilled for the last 3 months with symptom onsetat least 6 months prior to diagnosis with one or more of the followingsymptoms:upper abdominal (epigastric) pain/discomfort, postprandial fullness, early satiation, bloating, nausea and belching. 4.No evidence of any organic disease. 5.Subject should be able to provide a written informed consent
Exclusion criteria
Exclusion criteria: 1.Positive Helicobacter pylori test. 2.Any organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity. 3.Subject with known history of gastric bleeding, intestinal obstruction or perforation and previous gastrointestinal surgery. 4.Subjects with major systemic illness including cardiac disease, liver disease, kidney disease, diabetes, hypertension, inflammatory bowel disease, psycho-neuro-endocrinal disorders.) 5.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. 6.Subject currently taking drugs that may affect gastrointestinal motility (e.g., anticholinergic, Reglan, erythromycin, azithromycin, Domperidone, etc.), Buspirone, Acotiamide, Tramadol, nonsteroidal anti-inflammatory drug, 7.History of hypersensitivity to any of the trial drugs or their ingredients. 8.Pregnant or lactating women 9.Patients who are judged by the investigators to be unsuitable to participate in the clinical trial (diagnosed psychotic illnesses, substance dependence or alcoholism)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in Functional dyspepsia symptoms in Dyspepsia questionnaire. 2.Changes in symptoms of Amlapitta disease in Amlapitta Symptom Rating Scale 3.Satisfactory therapeutic response Timepoint: Time frame: baseline (0 week), 4 week, 8 week, 12 week, Post treatment follow up- Assessment at the end of 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Disease relapse rate after treatment success 2. Assessment of quality of life in Functional Dyspepsia patients by WHOQOL scale 3. Psychological Assessment by Becks Depression Inventory Scoring ScaleTimepoint: Time frame: baseline(0 week), 4 week, 8 week, 12 week,Post treatment follow up- Assessment at the end of 14 weeks | — |
Countries
India
Contacts
Public ContactDr NEHA DUBEY
REGIONAL AYURVEDA RESEARCH INSTITUTE FOR GASTROINTESTINAL DISORDERS,GUWAHATI
Outcome results
None listed