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

Last updated: January 30, 2024
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

Placebo

EQ-778

Clinical Study ID

NCT05835375
PL/221201/EQ/CCI
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activitylevel 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., associatedwith the study and to complete all clinical study visits.

Exclusion

Exclusion Criteria:

  1. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasalreconstructive surgery, etc.
  2. Known sensitivity to the investigational product or any excipients of the drugproduct.
  3. Any clinically significant abnormalities of the upper respiratory tract (such asstridor, 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 forcommon 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 bloodpressure ≥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 studyperiod.
  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 othermedications that are expected to alleviate cold symptoms within two weeks prior toscreening.
  13. History of any significant neurological and psychiatric condition which may affect theparticipation 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:
  16. Use of recreational drugs (such as cocaine, methamphetamine, marijuana,etc.)/Nicotine, tobacco or smoking dependence.
  17. High-risk drinking as defined by consumption of 4 or more alcohol containingbeverages on any day or 8 or more alcohol containing beverages per week for womenand 5 or more alcohol containing beverages on any day or 15 or more alcoholcontaining beverages per week for men.
  18. Individuals who have clinically significant following severe illness (i.e.,Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliarysystem, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory,blood and tumors, gastrointestinal diseases, etc.)
  19. Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.
  20. Any condition that could, in the opinion of the investigator, preclude theparticipant's ability to successfully and safely complete the study or that mayconfound study outcomes.

Study Design

Total Participants: 374
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
August 02, 2023
Estimated Completion Date:
April 26, 2024

Connect with a study center

  • Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar

    Ahmedabad, Gujarat 380052
    India

    Active - Recruiting

  • V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi

    Ahmedabad, Gujarat 380006
    India

    Active - Recruiting

  • Aman Hospital and Research Centre, 15, Shashwat, Opp. E.S.I Hospital, Gotri Road

    Vadodara, Gujarat 390021.
    India

    Site Not Available

  • AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East

    Dombivli, Maharashtra 421203
    India

    Active - Recruiting

  • Shree Ashirwad Hospital, C/3, Shree Complex, Opp. Mahavir Nagar, Manpada Road, Dombivli East

    Dombivli, Maharashtra 421201
    India

    Site Not Available

  • Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road

    Nashik, Maharashtra 422005
    India

    Active - Recruiting

  • Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar

    Nashik, Maharashtra 422009
    India

    Active - Recruiting

  • Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo

    Nashik, Maharashtra 422003
    India

    Active - Recruiting

  • Dhanwantri Hospital

    Pune, Maharashtra 411011
    India

    Active - Recruiting

  • Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi

    Pune, Maharashtra 411057
    India

    Active - Recruiting

  • Umarji Mother and Child Care Hospital, Balewadi Phata, Baner

    Pune, Maharashtra 411045
    India

    Active - Recruiting

  • Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East

    Vasai, Maharashtra 401208
    India

    Active - Recruiting

  • Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East

    Virār, Maharashtra 401209
    India

    Active - Recruiting

  • Janta Hospital & Maternity Centre

    Varanasi, Uttar Pradesh 221011
    India

    Active - Recruiting

  • Tulsi Hospital

    Delhi, 110094.
    India

    Active - Recruiting

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