A Study to Assess the Efficacy of CaroRite™ on Psychological Well-being, Oxidative Stress and Quality of Life in Healthy Individuals
NCT05931315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2024-04-15
Summary
The present study is a randomized, placebo-controlled, double-blind clinical study in which 94 individuals will be screened, and considering a screening failure rate of 20%, approximately 76 participants will be randomized in a ratio of 1:1 to receive either CaroRite™ or placebo and will be assigned a unique randomization code. Each group will have at least 30 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days.
Conditions
- Psychological Well-Being
- Oxidative Stress
- Quality of Life
Interventions
- DIETARY_SUPPLEMENT
-
CaroRite™
One capsule to be taken immediately post-dinner / with dinner
- DIETARY_SUPPLEMENT
-
Placebo
One capsule to be taken immediately post-dinner / with dinner
Sponsors & Collaborators
-
Vedic Lifesciences Pvt. Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-22
- Primary Completion
- 2024-03-15
- Completion
- 2024-03-15
Countries
- India
Study Locations
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