A clinical study to Compare the Safety and Effectiveness of Digifine Capsule and Pantoprazole plus Domperidone or Pantoprazole versus Pantoprazole plus Domperidone and Pantoprazole in Patients with Functional dyspepsia
- Conditions
- Health Condition 1: K929- Disease of digestive system, unspecified
- Registration Number
- CTRI/2022/12/048631
- Lead Sponsor
- Dr Ranjana G Deshmukh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 Investigators 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 investigators evaluation of patients lifestyle which may interfere with safety of patients or treatment evaluation while participating in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method