None listed
Conditions
Interventions
Two groups will be formed and they will be distributed randomly. After being diagnosed, subjects will be assigned to one of two treatments. One group of patients will receive Combizym® Compositum for
Sponsors
DEUTSCHE PHARMA S.A.C.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign and date an inform consent form according Good Clinical Practices guidelines and local regulations approved by ethics committee in research where explains all aspects of the protocol. 2. Subjects both sexes between 18 to under 65 years of age. 3. Diagnosis of functional dyspepsia having been discard digestive organic disorders that could explain the patient´s symptoms. 4. One or more symptoms of dyspepsia including: bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning. 5. Willingness to adhere to the treatment program.
Exclusion criteria
Exclusion criteria: 1. Participation in another research study concurrently or within the last thirty (30) days. 2. A significant clinical or psychiatric disorder, acute or chronic, which at the investigator’s judgement, may endanger the subject’s safety, limits the subject’s ability to complete the study, and/or affects the objectives of the study. 3. Subjects who had been treated with H2 receptor antagonists, prokinetic agents and use of digestive enzymes within 7 days of the Screening Visit ((Visit 1), or who have programed to receive any of the products during the study. Oral analgesic products are not allowed except for PRN paracetamol. 4. Subjects with organic digestive disorders, severe hepatic failure, biliary tract obstruction, vesicular empyema or gastrointestinal infections. 5. Subjects with serious pulmonary or cardiovascular disorders, late stage cancer, unstable chronic diseases or acute diseases that may influence the evaluation of the study. 6. Allergy history or hypersensitivity to investigational product or any of its components. 7. Female subjects who are pregnant of breast-feeding. 8. Female patients of reproductive age who are not using appropriate efficient contraceptive methods. 9. Investigators, staff medical center directly affiliated with this study and their immediate families. It is defined as an immediate family member / a husband / wife, father / mother, son or descendant, whether biological or legally adopted.
Countries
Peru
Contacts
Public ContactAntonia Indira Solano
LATINOAMERICANA DE CIENCIAS S.A.C.
Outcome results
None listed