Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Digifine 40 mg Capsules: 1 capsule three times daily before food for 30 days
Control Intervention1: Pantoprazole Tablet, 40 mg: 1 tablet three times daily before food for 30 days
Contro
Sponsors
Dr Ranjana G Deshmukh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients between 18 to 60 years (both ages inclusive) 2. Patients with functional dyspepsia as per ROME IV criteria and currently not receiving any treatment since at least two weeks prior to screening (ROME IV criteria can be referred) 3. Patients had an upper endoscopy performed within 3 months before screening that showed no evidence of structural disease that was likely to explain the dyspepsia symptoms. 4. Patients willing to give their written informed consent to participate in the study and able to record answers on study-related questionnaires 5. Patients willing to comply with all aspects of the protocol
Exclusion criteria
Exclusion criteria: 1. Patients hypersensitive to active or inactive ingredients of investigational products 2. Patient with history of taking medicines responsible for QT prolongation 3. Patients with history of cardiac disorder (clinically significant bradycardia, sinus node dysfunction, prolonged QTc, cardiac conduction intervals, history of arrhythmia or at risk of serious ventricular arrhythmias) 4. Patients with history of clinically significant hepatic dysfunction, renal insufficiency, electrolyte disorders, which in the opinion of the investigator might affect patientâ??s safety while participating in the study or affect study treatment result analysis 5. Patients with history of gastrointestinal hemorrhage or obstruction or having any symptoms suggestive of gastrointestinal hemorrhage or obstruction or prolactinoma 6. Patients who have history significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure, hepatic diseases or renal disease as per investigatorâ??s judgment may impact the efficacy analyses for the study or put the Patientâ??s safety at risk based on prescribing information of pantoprazole and/or domperidone 7. Female patients who are pregnant, lactating, or planning to become pregnant 8. Patients (male and female both) not willing to use acceptable method of contraception 9. Patients scheduled to undergo surgery during the study period 10. Patients who have received any intervention in a clinical trial within 01 month prior to screening 11. Patients with history of alcohol or substance abuse which as per Investigator"s which may interfere with safety of patients or treatment evaluation while participating in the study 12. Current significant alcohol consumption or smoking tobacco based on investigator"s evaluation of patient"s lifestyle which may interfere with safety of patients or treatment evaluation while participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage change in global overall symptom scale on Visit 2/Day 15 (±4days) days of treatment from baseline as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B) 2. Percentage change in global overall symptom scale on Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14 as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B)Timepoint: 1. Visit 2/Day 15 (±4days) days of treatment from baseline 2. Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with adequate relief on Visit 2 and Visit 3 from baseline as assessed by total symptom score recorded under functional dyspepsia diary questions Adequate relief defined as more than 50 percent reduction in the total symptom score based on functional dyspepsia symptom diaryTimepoint: Visit 2 and Visit 3 from baseline;Proportion of patients with decrease in severity of each symptom score assessed from functional dyspepsia symptom diary on Day 3 and Day 6 and Day 9 and Day 12 and Day 18 and Day 21 and Day 24 from baselineTimepoint: Day 3 and Day 6 and Day 9 and Day 12 and Day 18 and Day 21 and Day 24;Proportion of patients with adequate relief on Day 7 and Day 21 period from baselineTimepoint: Day 7 and Day 21 period from baseline | — |
Countries
India
Contacts
Public ContactDr Ranjana G Deshmukh
Dr. Hedgewar Rugnalaya
Outcome results
None listed