Health Condition 1: null- Patients with functional dyspepsia diagnosed by rome 3 criteria
Conditions
Interventions
None listed
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients clinically diagnosed with functional dyspepsia where physician has taken decision to prescribe acotiamide hydrochloride hydrate. 2.Patients with Functional Dyspepsia as defined by Rome III criteria Diagnostic criteria Must include: One or more of the following: a. Bothersome postprandial fullness b. Early satiation c. Epigastric pain d. Epigastric burning and No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Exclusion criteria
Exclusion criteria: 1. Patients with a known or suspected hypersensitivity to acotiamide or to any ingredients of the formulation 2. Patients on cholinergic drugs as part of therapy 3. Patients on prokinetics as a part of therapy 4. Structural lesion evident in endoscopy 5. Coexisting Irritable bowel syndrome 6. Heartburn in past 12 weeks 7. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of acotiamide hydrochloride hydrate in overall treatment efficacy, will be recorded using the 7 point Likert scale questionnaire at the end of 2 weeks and 4 weeks compared to baseline. Patients whose symptoms are â??Extremely improved â??and â??improvedâ?? in Likert scale are to be considered as responders Timepoint: 2 and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of acotiamide hydrochloride hydrate in elimination of all three symptoms (post prandial fullness, upper abdominal bloating, early satiety) using a symptom scale (severe-3,moderare-2,mild-1,none-0) Disease specific quality of life index using SF NDI ( short form Napean Dyspepsia Index for QOL measurement) at the end of 2 weeks and 4 weeks compared to baseline. Timepoint: 2 and 4 weeks | — |
Countries
India
Contacts
Public ContactV Krishna chaitanya
Gandhi hospital
Outcome results
None listed