Clinical trial NCT05835375: A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Respiratory Tract Infection
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group, double-blind, placebo-controlled trial
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
2. BMI ≥ 18.5 and ≤ 34.9 kg/m2
3. High susceptibility to URTIs (≥ 3 and ≤ 6 episodes within 12 months)
4. Commitment to adhere to routine diet and physical activity.
5. Willing to consume IP or placebo, complete questionnaires, records, etc., associated with the study and to complete all clinical study visits.

Exclusion Criteria:

1. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
2. Known sensitivity to the investigational product or any excipients of the drug product.
3. Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc)
4. Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc)
5. Chronic cough of any origin
6. Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc.
7. Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose ≥ 126 mg/dL
8. Individuals with uncontrolled hypertension on medication and with systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded.
9. Unable to abstain from herbal or dietary supplements for URTI throughout the study period.
10. Vaccination against influenza or swine flu within 3 months prior to screening.
11. Individuals with COVID infection in the last 30 days
12. 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.
13. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
14. Participation in other clinical trials in last 30 days prior to screening
15. Individuals with substance abuse problems (within 2 years) defined as:

    1. Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence.
    2. 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.
16. 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.)
17. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
18. 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.

Primary outcomes:
measure: 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.
timeFrame: 180 Days
Secondary outcomes:
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: During episodes of URTI throughout the study
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0 and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 and during each URTI episode
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
measure: To evaluate the effect of the IP as compared to placebo
timeFrame: On the last day of the URTI episode.
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
state: Gujarat
city: Ahmedabad
country: India
facility: Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
state: Gujarat
city: Dombivli
country: India
facility: AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
state: Maharashtra
city: Nashik
country: India
facility: Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo
state: Maharashtra
city: Nashik
country: India
facility: Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
state: Maharashtra
city: Nashik
country: India
facility: Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
state: Maharashtra
city: Pune
country: India
facility: Dhanwantri Hospital
state: Maharashtra
city: Pune
country: India
facility: Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
state: Maharashtra
city: Pune
country: India
facility: Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
state: Maharashtra
city: Vasai
country: India
facility: Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
state: Maharashtra
city: Virār
country: India
facility: Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
state: Maharashtra
city: Varanasi
country: India
facility: Janta Hospital & Maternity Centre
state: Uttar Pradesh
city: Delhi
country: India
facility: Tulsi Hospital
Study officials:
References: