The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)
Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)
Life care hospital
Nashik, Maharashtra, India
RECRUITINGENT Vertigo Clinic
Pune, Maharashtra, India
RECRUITINGJawaharlal Nehru Medical College
Ajmer, Rajasthan, India
RECRUITINGHuman Care Hospital
Lucknow, Uttar Pradesh, India
RECRUITINGShubham Sudbhawana Super Speciality Hospital
Varanasi, Uttar Pradesh, India
RECRUITINGJanta Hospital
Varanasi, Uttar Pradesh, India
NOT_YET_RECRUITINGGastron Clinic
Delhi, India
RECRUITINGGood health Clinic
Delhi, India
RECRUITINGTulsi Multispecility Hospital
Delhi, India
RECRUITINGTo evaluate the effect of investigational products on participant's severity of common cold like symptoms
evaluated by Wisconsin Upper Respiratory Symptom Survey-21 total severity score (incremental Area Under the Curve (iAUC) The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.
Time frame: During Upper respiratory tract infection episodes throughout the study upto 7 day Treatment duration
To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms
resolution deemed to occur when participant reports being "0 = not sick" as per Wisconsin Upper Respiratory Symptom Survey-21 for two consecutive days during the treatment period, The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms
being those who do not report being "0 = not sick" as per Wisconsin Upper Respiratory Symptom Survey-21 till the end of the treatment period. An episode is deemed resolved when the participant marks "0 = not sick" on Q.1 of WURSS-21 for two consecutive days. If this criterion is not met, the episode is considered unresolved
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study)
The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale.
Place the thermometer in the armpit. Press the arm against the body. Wait for 2-3 minutes before reading in case of traditional thermometer or until it beeps in case of digital thermometer. The number of days taken to be afebrile (temp \< 100 oF or \< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline will be recorded. The participants will record their fever daily on diary
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage population with fever during the study.
Place the thermometer in the armpit. Press the arm against the body. Wait for 2-3 minutes before reading in case of traditional thermometer or until it beeps in case of digital thermometer. The number of days taken to be afebrile
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life
The Wisconsin Upper Respiratory Symptom Survey-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.All the items will be scored on an 8-point Likert scale ranging from 0 which depicts "absent or no impairment" through 1 (very mild), 3 (mild), 5 (moderate) and 7 (severe)
Time frame: Day 0, day 4 and day 8
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