The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical studydesigned to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%,approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active orplacebo. The study will have at least 100 completed participants i.e. 50 participants in each studyarm after accounting for a dropout/withdrawal rate of 30% at the end of the study. The interventionand follow-up duration for all the study participants will be 120 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
one capsule once a day with/beforebreakfast for 120 days
one capsule once a day with/beforebreakfast for 120 days
Nand Hospital
Vadodara, Gujarat, India
Lifeline Clinicand Diagnostics
Nashik, Maharashtra, India
AMF MorayaMultispecialityHospital
Pune, Maharashtra, India
ENT and VertigoClinic
Pune, Maharashtra, India
Madhumeh Clinic
New Delhi, National Capital Territory of Delhi, India
Janta Hospital &MaternityCentre
Varanasi, Uttar Pradesh, India
To Measure the effect of the 120 days' administration of IP on %population having one or more episodes of URTI during the study duration asassessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire as compared to baseline and placebo.
The WURSS-21 includes nine items assessing the impact of the URTI episode on an individual's quality of life i.e., the ability to think clearly, sleep well, breathe easily, exercise, work inside and outside the home, accomplish daily activities, interact with others and live one's personal life. All the items will be scored on an 8-point Likert scale ranging from 0 which depicts "absent or no impairment" to 1 (very mild), 3 (mild) 5(moderate), and 7 (severe). Participants will be instructed to fill this questionnaire whenever they have a URTI episode on all days throughout the study. An average of all WURSS-21 QoL scores will be calculated for every episode and considered to analyze the change in QoL as compared to baseline and placebo.
Time frame: Day 30,Day 90 & Day 120
To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire(WURSS-21)
In WURSS-21 All the items will be scored on an 8-point Likert scale ranging from 0, which depicts "absent or no impairment", to 1 (very mild), 3 (mild), 5 (moderate), and 7 (severe).43 The global score of WURSS-21 (question no. 1-19) ranges from 0-133 per day. Higher scores represent higher severity
Time frame: From Date of Randomization upto 120 days
To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Number of URTI episodes
the number of URTI episodes (frequency) and proves to be beneficial in individuals suffering from frequent URTI episodes
Time frame: From Date of Randomization upto 120 days
To Measure the effect of IP in comparison to baseline and placebo on -Body composition (Fat tissue, lean mass, fat free mass) as assessedby Dual Energy X-ray Absorptiometry -Gut microbiome analysis as assessed by Next Generation Sequencing
Dual Energy X-ray Absorptiometry Scans can assess fat content and total body composition with a high degree of precision that is comparable to hydrostatic weighing The investigation of the gut microbiota in a culture-independent manner has been made possible by next-generation sequencing technology, which has provided insights into the intricate and little-understood interactions between the gut microbiome and its host
Time frame: Day 0 and Day 120
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