Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Sponsors
Advanced Vital Enzymes Private limited
Milagro Clinical Research
Eligibility
Inclusion criteria
Inclusion criteria: The Inclusion criteria are as follows (â??Yesâ?? to all the following will allow the subjects to be included into study) 1. Age: Adult-Above 18 years to 60 years, both male and female 2. Willing to sign written inform consent 3. Patients diagnosed one of the following signs and symptoms of indigestion Abdominal discomfort Flatulence Burping or belching Acidity and pain Heaviness in upper abdomen. 4. Availability throughout the study period. 5. Having traceable geographical address for follow-up.
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows (â??Yesâ?? to any one of the following will allow PI to exclude the subject from enrolling into the study 1. Known allergy to any of the ingredients present in investigational product or active control. 2. Allergic reactions to enzymes of similar composition. 3. Gastrointestinal disease or other condition resulting in inability to take oral medications 4. Patients on restricted sodium diet i.e., hypertensive or suffering from congestive cardiac failure 5. Renal or hepatic impairment. 6. Uncontrolled heart disease or other serious chronic disease 7. Radiotherapy within 4 weeks prior to randomization 8. Patients suffering from chronic major illness, like Jaundice, AIDS, Cancer, Tuberculosis, Diabetes Mellitus, Hepatitis B or C positive etc. 9. Use of investigational agents within 4 weeks of randomization. 10. Treatment with any medication which could alter or influence stomach acidity or test drug/placebo activity 11. Concurrent systemic corticosteroid therapy within 4 weeks of randomization. 12. Seriously ill and moribund patients with complications. 13. Patients unable to comply with the treatment regimen. 14. Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test 15. Surgery of Gastrointestinal tract 16. Participation in other clinical trials in the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Enzoveda#001 as a food supplement with ENO® in patients suffering from indigestionTimepoint: 7 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic relief from clinical symptoms of IndigestionTimepoint: 7 Days | — |
Countries
India
Contacts
Public ContactTrupti Desai
Milagro Clinical Research
Outcome results
None listed