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

January 30, 2024 updated by: Vedic Lifesciences Pvt. Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Delhi, India, 110094.
        • Recruiting
        • Tulsi Hospital
        • Contact:
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Recruiting
        • V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
        • Contact:
      • Ahmedabad, Gujarat, India, 380052
        • Recruiting
        • Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
        • Contact:
    • Maharashtra
      • Dombivli, Maharashtra, India, 421203
        • Recruiting
        • AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
        • Contact:
      • Nashik, Maharashtra, India, 422003
        • Recruiting
        • Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo
        • Contact:
      • Nashik, Maharashtra, India, 422005
        • Recruiting
        • Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
        • Contact:
      • Nashik, Maharashtra, India, 422009
        • Recruiting
        • Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
        • Contact:
      • Pune, Maharashtra, India, 411011
      • Pune, Maharashtra, India, 411045
        • Recruiting
        • Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
        • Contact:
      • Pune, Maharashtra, India, 411057
        • Recruiting
        • Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
        • Contact:
      • Vasai, Maharashtra, India, 401208
        • Recruiting
        • Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
        • Contact:
      • Virār, Maharashtra, India, 401209
        • Recruiting
        • Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
        • Contact:
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221011
        • Recruiting
        • Janta Hospital & Maternity Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EQ-778
  1. capsule to be taken daily after breakfast (in case no URTI episode)
  2. capsules to be taken daily after breakfast (in case of URTI episode)
Other: EQ-778
  1. capsule daily after breakfast (in case of no URTI episode);
  2. capsules after breakfast (in case of URTI episode)
Placebo Comparator: Placebo
  1. capsule to be taken daily after breakfast (in case no URTI episode)
  2. capsules to be taken daily after breakfast (in case of URTI episode)
Other: Placebo
  1. capsule daily after breakfast (in case of no URTI episode);
  2. capsules after breakfast (in case of URTI episode)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 180 Days
180 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of the IP as compared to placebo
Time Frame: During episodes of URTI throughout the study
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
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
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
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
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
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
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
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
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
Time Frame: Day 0 and Day 180
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 and during each URTI episode
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
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
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
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
Time Frame: On the last day of the URTI episode.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

April 26, 2024

Study Completion (Estimated)

April 26, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL/221201/EQ/CCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Upper Respiratory Tract Infection

Clinical Trials on EQ-778

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe