A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults

Study Overview
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Brief Summary
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This study is a randomized, double-blind, Placebo Controlled study to evaluate the efficacy of 180 days administration of EQ-778 on upper respiratory tract health status in healthy adults

Official Title
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A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults

Conditions
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Upper Respiratory Tract Infection

Intervention / Treatment
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* Other: EQ-778
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF) BMI ≥ 18.5 and ≤ 34.9 kg/m2 High susceptibility to URTIs (≥ 3 and ≤ 6 episodes within 12 months) Commitment to adhere to routine diet and physical activity. Willing to consume IP or placebo, complete questionnaires, records, etc., associated with the study and to complete all clinical study visits. Exclusion Criteria: History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc. Known sensitivity to the investigational product or any excipients of the drug product. Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc) Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc) Chronic cough of any origin Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc. Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose ≥ 126 mg/dL Individuals with uncontrolled hypertension on medication and with systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded. Unable to abstain from herbal or dietary supplements for URTI throughout the study period. Vaccination against influenza or swine flu within 3 months prior to screening. Individuals with COVID infection in the last 30 days Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDS (paracetamol) or other medications that are expected to alleviate cold symptoms within two weeks prior to screening. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points. Participation in other clinical trials in last 30 days prior to screening Individuals with substance abuse problems (within 2 years) defined as: Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men. Individuals who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.) Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel group, double-blind, placebo-controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EQ-778<br>capsule to be taken daily after breakfast (in case no URTI episode) capsules to be taken daily after breakfast (in case of URTI episode) | Other: EQ-778<br>* capsule daily after breakfast (in case of no URTI episode); capsules after breakfast (in case of URTI episode)<br>|
| Placebo Comparator: Placebo<br>capsule to be taken daily after breakfast (in case no URTI episode) capsules to be taken daily after breakfast (in case of URTI episode) | Other: Placebo<br>* capsule daily after breakfast (in case of no URTI episode); capsules after breakfast (in case of URTI episode)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess effect of administration of IP on the severity of Upper respiratory tract infections (URTI) symptoms as assessed by area under curve (AUC) for Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) symptom severity score. |  | 180 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of the IP as compared to placebo | Nasal Viral load as assessed by TRU-PCR analysis | During episodes of URTI throughout the study | 
| To evaluate the effect of the IP as compared to placebo | Change in participants' URTI symptoms severity as compared to the previous day | On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180) | 
| To evaluate the effect of the IP as compared to placebo | Change in frequency of current URTI episodes rates as compared to the self-reported historical frequency of URTI in previous 6 months before study begins | On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180) | 
| To evaluate the effect of the IP as compared to placebo | Percentage of population suffering having one or more episode of URTIs during study. | On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180) | 
| To evaluate the effect of the IP as compared to placebo | The time taken for resolution of the symptoms of the URTIs by eDiary records | On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180) | 
| To evaluate the effect of the IP as compared to placebo | Change in quality of life using the WURSS-21 questionnaire (in eDiary, as and when the subject gets an episode - recall period: last 24 hours) | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | Immunity as assessed by the change in salivary IgA from baseline | Day 0 and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | Sleep quality assessed by Pittsburgh Sleep Quality Index | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | Mood as assessed by Visual Analogue Scale (VAS) | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | Stress measured by Perceived Stress Scale (PSS) | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 and during each URTI episode | 
| To evaluate the effect of the IP as compared to placebo | General fatigue as assessed by Fatigue Severity Scale (FSS) | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | To assess the effect of the IP on the consumption of rescue medication | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | To assess the impact of the intervention on daily routine activities by a VAS scale | Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | 
| To evaluate the effect of the IP as compared to placebo | To assess the impact of the IP on mood, stress, fatigue, sleep quality and physical activity as assessed by a VAS scale | On the last day of the URTI episode. |