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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
78
One capsule to be taken immediately post-dinner / with dinner
One capsule to be taken immediately post-dinner / with dinner
Dr. Praphulla Awate's Clinic
Mumbai, Maharashtra, India
The Kewalramani Clinic
Mumbai, Maharashtra, India
Sangvi Hospital
Pune, Maharashtra, India
Saikrupa Hospital
Pune, Maharashtra, India
To assess the impact of the Investigational Product (IP) on psychological well-being using the Psychological General Well-Being Index (PGWBI).
The PGWBI comprises of six sub-scales assessing the positive and negative states on a six-point Likert scale (0 = absence of psychological well-being; to 5 = high levels of well-being). Scores between 0 and 60 indicate severe distress, between 61 and 72 reflect moderate distress, and between 73 and 110 indicate a positive psychological well-being.
Time frame: Day 90
Oxidative stress as assessed by decrease in serum levels of 8-Isoprostanes.
The normal reference range of 8-isoprostanes is 2-34 pg/ml
Time frame: Day 90
Immune Status as assessed by the increase in salivary IgA levels.
The normal reference range of IgA levels are: male 28.0 - 188.2 ng/ml; female 32.4 - 156.8 ng/ml.
Time frame: Day 90
Quality of life as assessed by increase in the scores of SF-36 questionnaire.
The SF-36 includes multi-item scales to measure the following 8 dimensions (refer 15.2 for questionnaire): PF- Physical functioning (10 items in question 3) RP- Role limitations due to physical health problems (4 items in question 4) BP- Overall body pain (questions 7 and 8) SF- Social functioning (questions 6 and 10) MH - General mental health, covering psychological distress and well-being (5 items: questions 9 b, c, d, f and h) RE- Role limitations due to emotional problems (questions 5 a, b and c) VT- Vitality, energy or fatigue (4 items: questions 9 a, e, g and i) GH- General health perceptions (5 items: questions 1 and 11 a to d)
Time frame: Day 90
Sleep quality as assessed by the decrease in the PSQI score
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). All the seven component scores are to be added together for calculating the Global PSQI Score. Higher scores indicate worse sleep quality
Time frame: Day 90
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