Clinical study on OptimaLiv Capsule

An open labelled, multi-center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of OptimaLiv Capsule in healthy participants.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046222

Enrollment

Registered

2022-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: OptimaLIV capsule: Subjects will be asked to take OptimaLiv in a dose of 1 capsule twice daily orally after meals with water for 2 months Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Changes in Liver-Ultra Sonography 2. Change in Liver functions 3. Changes in clinical symptoms (if any) 4. Changes in clinical symptoms related to skin (if any) 5. Changes in energy, strength, stamina 6. Assessment of immunity through episodes, severity and duration of illness (infections or allergies) 7. Change in quality of life assessed on WHO QOL BREF 8. Change in lipid profile levels 9. Change in Weight and BMI 10. Global assessment of overall change by investigator and subject 11. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms 12. Assessment of adverse events 13. Changes in pre and post product consumption safety laboratory investigations Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60.	—

Measure

Time frame

1. Changes in Liver-Ultra Sonography 2. Change in Liver functions 3. Changes in clinical symptoms (if any) 4. Changes in clinical symptoms related to skin (if any) 5. Changes in energy, strength, stamina 6. Assessment of immunity through episodes, severity and duration of illness (infections or allergies) 7. Change in quality of life assessed on WHO QOL BREF 8. Change in lipid profile levels 9. Change in Weight and BMI 10. Global assessment of overall change by investigator and subject 11. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms 12. Assessment of adverse events 13. Changes in pre and post product consumption safety laboratory investigations Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60.

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results