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

Upper Respiratory Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835375
• Other study ID #: PL/221201/EQ/CCI
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: April 26, 2024

Study information

• Verified date: January 2024
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: Dr. Shalini Srivastava, MBBS, MD
• Phone: 42172300
• Email: shalini.s[@]vediclifesciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Other:
• EQ-778
capsule daily after breakfast (in case of no URTI episode); capsules after breakfast (in case of URTI episode)
• Placebo
capsule daily after breakfast (in case of no URTI episode); capsules after breakfast (in case of URTI episode)

Locations

Country	Name	City	State
India	Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar	Ahmedabad	Gujarat
India	V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi	Ahmedabad	Gujarat
India	Tulsi Hospital	Delhi
India	AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East	Dombivli	Maharashtra
India	Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road	Nashik	Maharashtra
India	Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar	Nashik	Maharashtra
India	Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo	Nashik	Maharashtra
India	Dhanwantri Hospital	Pune	Maharashtra
India	Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi	Pune	Maharashtra
India	Umarji Mother and Child Care Hospital, Balewadi Phata, Baner	Pune	Maharashtra
India	Janta Hospital & Maternity Centre	Varanasi	Uttar Pradesh
India	Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East	Vasai	Maharashtra
India	Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East	Virar	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.