Health Condition 1: - Health Condition 2: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: ACOTIAMIDE: 300 MG OD ORALLY FOR 1 MONTH
Control Intervention1: PLACEBO DRUG: ONCE DAILY ORALLY FOR 1 MONTH
Sponsors
Payel Chakraborty
Eligibility
Inclusion criteria
Inclusion criteria: 1)No upper GI abnormality in upper GI endoscopy 2)Symptoms of dyspepsia for atleast 1 month
Exclusion criteria
Exclusion criteria: 1.Patient with abnormal upper GI endoscopy. 2. Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hematemesis, melena, fever, jaundice, or anemia), 3. Recent gastrointestinal surgery i.e. within 30 days. 4. Patients who show any of the following values at the baseline laboratory tests: severe anaemia, total leukocyte count 3,000/mm3 , platelet count , AST and ALT � 100 IU/L, Creatinine � 1.5 mg/dL The blood tests should have been done not more than 4 weeks prior to enrollment. 5.Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment. 6. Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs. 7.History of hypersensitivity to either of the study drugs or closely allied drugs. 8. Women who are pregnant, lactating, or not willing to use adequate methods of contraception. 9.Any other condition which can lead the study investigators to consider the subject unsuitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of acotiamide in releiving symptoms (Abdominai pain,heart burn,reflux,vomitting,distension of abdomen)Timepoint: First visit,2 week & 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the treatmemt emergent adverse event of acotiamide clinically & laboratory parametersTimepoint: First visit & 4 week | — |
Countries
India
Contacts
Public ContactProf Dr Asoke Kumar Das
College of medicine and sagore dutta hospital
Outcome results
None listed