Evaluating EQ-778 for improving upper respiratory tract health in healthy adults

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

Not applicable Interventional Vedic Lifesciences Pvt. Ltd. · NCT05835375

This study is testing a new product called EQ-778 to see if it can help healthy adults aged 18 to 50 improve their upper respiratory health and reduce the number of infections they get.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment374 (estimated)
Ages18 Years to 50 Years
SexAll
SponsorVedic Lifesciences Pvt. Ltd. Industry-sponsored
Locations13 sites (Ahmedabad, Gujarat and 12 other locations)
Trial IDNCT05835375 on ClinicalTrials.gov

What this trial studies

This study is a randomized, double-blind, placebo-controlled evaluation of EQ-778, focusing on its efficacy in enhancing upper respiratory tract health status among healthy adults. Participants aged 18 to 50, who are moderately active and have a history of upper respiratory tract infections, will receive either the investigational product or a placebo over a period of 180 days. The study aims to assess the impact of EQ-778 on the frequency and severity of upper respiratory tract infections through questionnaires and clinical visits.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 50 with a history of multiple upper respiratory tract infections.

Not a fit: Patients with significant respiratory illnesses or anatomical abnormalities of the upper respiratory tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive treatment option for individuals prone to upper respiratory tract infections.

How similar studies have performed: While similar studies have explored treatments for upper respiratory infections, the specific approach with EQ-778 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Ahmedabad, Gujarat and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Upper Respiratory Tract Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.