None listed
Conditions
Interventions
None listed
Sponsors
Naturedge Beverages Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects aged 18 to 60 years (both the ages inclusive) Ready to provide written informed consent Willing to come for the follow-up visits for evaluation With or without comorbidity and according to investigator discretion.
Exclusion criteria
Exclusion criteria: Presence of clinically significant known abnormal laboratory, ECG or X-ray findings during screening. Patients with known uncontrolled diabetes mellitus (DM) HbA1C more than 7.5, hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI) Subjects with current medical history of any major illness such as cancer, heart disease, COPD, Asthma etc. in the past Patients participated in another clinical drug trial within 3 months before recruitment in this trial Any other medical condition that in the Investigators opinion would preclude patient participation Pregnant and breast feeding women and women of child bearing age refusing to use contraceptive measures Immunologically compromised individuals Subjects with past history of addiction abuse and rehabilitation Subject consuming more than 1 cigarette per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in Quality of life of subjects by GHQ-29 questionnaire 2.Changes in digestive complaints (Bloating, Heartburn, Flatulence, Constipation, Post Prandial Fullness etc.) in subjects 3.Changes in digestive behavior questionnaire (Gut health) 4.Changes in energy audit questionnaire scoreTimepoint: Screening, Baseline, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Liver function parameters 2.Tolerability of intervention by study subjectsTimepoint: Screening, Baseline, Day 30 | — |
Countries
India
Contacts
Public ContactMr Sharad Dhurde
Naturedge Beverages Pvt. Ltd.
Outcome results
None listed