Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
None listed
Sponsors
Fourrts pharmaceutical company
Eligibility
Inclusion criteria
Inclusion criteria: FUNCTIONAL DYSPEPSIA (Roams 4 criteria) - Must include one or more of the following bothersome symptoms at least 4 times a month for at least 2 months prior to diagnosis: Postprandial fullness Early satiation Epigastric pain or burning not associated with defecation After appropriate evaluation, the symptoms cannot be fully explained by another medical condition Within FD(Functional dyspepsia) the following subtypes are now adopted: H2a1.  Postprandial distress syndrome includes bothersome postprandial fullness or early satiation which prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching. H2a2.  Epigastric pain syndrome which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component, (b) commonly induced or relieved by ingestion of a meal but may occur while fasting.
Exclusion criteria
Exclusion criteria: 1.Patient already on treatment with Proton pump inhibitors (PPI) /H2RA, Prokinetics ,NSAIDS or within 1 week of study commencement 2.Previous Gastrointestinal surgery and diseases (e.g. â?? ulcerative colitis, crohnâ??s disease) 3.Chronic systemic illness (liver,heart,renal diseases) 4.History of H. Pylori infection and treatment in last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of lansoprazole vs placebo on participants for complete relief of epigastric pain and postprandial distress during the last 3 days of 4 week treatment Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1).Relief from other gastrointestinal symptoms like : nausea ,upper abdominal bloating , excessive belching , heartburn at day 7 , 14 and 28 2).Evaluate the participants at day 7 and 14 for complete relief of epigastric pain and postprandial distress i.e. early improvement Timepoint: day 7 ,day 14 ,day 28 | — |
Countries
India
Contacts
Public ContactMohammad Saif Chaudhary
Eras lucknow medical college
Outcome results
None listed