Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of age group between 18-60 years are included in the study. 2. Subjects who are considered to healthy systemically without any comorbidities and malignancy are included in the study. 3. Subjects fulfilling the Rome Diagnostic criteria are included in the study. 4. Subjects with abdominal pain irrespective of underlying diagnosis related toGastro-Intestinal system are included in the study. 5. Subjects with complaints of frequent occurrences of abdominal pain due to natureof the disease are included in the study. 6. Subjects who are willing to give informed consent without any hindrance areincluded in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects below 18 years and above 60 years of age are excluded from the study. 2. Subjects with complaints of abdominal spasms due to other systemic diagnosis apart from Gastro-Intestinal systems such as renal calculi, gall bladder stones, etc, are excluded from the study. 3. Subjects who are not willing to give informed consent are excluded from the study. 4. Subjects with co morbidities such as; Type 2 Diabetes mellitus, hypothyroidism, Hypertension are excluded from the study. 5.Subjects who have been diagnosed of chronic diseases such as cardiovascular diseases, cancer, respiratory conditions, orthopaedic conditions associated with early and late complications are excluded from the study 6. Subjects who are associated with long tern usage of analgesics & who has pasthistory of Gastro-intestinal surgery are excluded from the study. 7. Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia &odynophagia are excluded from the study. 8. Subjects with persistent GI bleeding and frequent vomiting are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was a decrease in VAS for pain intensity.Timepoint: day 0 and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess Adverse eventsTimepoint: Day 1 to Day 30;To assess Gastrointestinal Symptom Rating Scale(GSRS)Timepoint: Day 1 to Day 30;To assess Global overall symptom scaleTimepoint: Day 1 to Day 30;To assess the Nepean Dyspepsia Index (NDI)Timepoint: Baseline , Day 1 to Day 30 | — |
Countries
India
Contacts
Pharexcel Consulting Private Limited