Clinical study on OptimaLiv Capsule
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy males and females with mild to moderate digestive complaints (Healthy individuals will be defined as those who are not taking any medications and do not require continuous medical care and monitoring)
2. Ready to provide written consent and follow all the study procedure
1.Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases,
2.Subjects having jaundice or any other symptom of active hepatitis
3.Subjects with any other investigational product within 1 month prior to randomization.
4.Subjects with diabetes mellitus and hypertension taking regular medications
5.Pregnant and lactating women
6.Subjects with any significant abnormal laboratory parameters
7.Known hypersensitivity to any of the ingredients of OptimaLIV Capsules
8.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in clinical characteristics/symptoms of healthy Liver functions through assessment of digestion related symptomsTimepoint: Day 0, Day 15, Day 30, Day 45 and Day 60.
- Secondary Outcome Measures
Name Time Method 1.Changes in Liver-Ultra Sonography <br/ ><br>2.Change in Liver functions <br/ ><br>3.Changes in clinical symptoms (if any) <br/ ><br>4.Changes in clinical symptoms related to skin (if any) <br/ ><br>5.Changes in energy, strength, stamina <br/ ><br>6.Assessment of immunity through episodes, severity and duration of illness (infections or allergies) <br/ ><br>7.Change in quality of life assessed on WHO QOL BREF <br/ ><br>8.Change in lipid profile levels <br/ ><br>9.Change in Weight and BMI <br/ ><br>10.Global assessment of overall change by investigator and subject <br/ ><br>11.Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms <br/ ><br>12.Assessment of adverse events <br/ ><br>13.Changes in pre and post product consumption safety laboratory investigations <br/ ><br>Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60.