Pilot clinical study of Digestive Enzyme.
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2019/03/018214
- Lead Sponsor
- Advanced Vital Enzymes Private limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
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. Patients below 18 years and above 60 yrs.
2. Not willing to sign written inform consent
3. Allergic reactions to enzymes of similar composition.
4. Gastrointestinal disease or other condition resulting in inability to take oral medications
5. Uncontrolled heart disease or other serious chronic disease
6. Radiotherapy within 4 weeks prior to randomization
7. Patients suffering from chronic major illness, like- Hypertnesion, Jaundice, AIDS, Cancer, Tuberculosis, Diabetes Mellitus, Hepatitis B or C positive etc
8. Use of investigational agents within 4 weeks of randomization
9. Concurrent systemic corticosteroid therapy within 4 weeks of randomization.
10. Seriously ill and moribund patients with complications.
11. Patients unable to comply with the treatment regimen.
12. Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess efficacy of Enzoveda#001 as a food supplement in patients suffering from indigestion and mean change in Visual Analogue Scale (VAS) from baseline to end of treatment.Timepoint: 7 days
- Secondary Outcome Measures
Name Time Method Symptomatic relief from the symptoms of IndigestionTimepoint: 7 days