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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 374 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Vedic Lifesciences Pvt. Ltd. Industry-sponsored |
| Locations | 13 sites (Ahmedabad, Gujarat and 12 other locations) |
| Trial ID | NCT05835375 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
- V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi — Ahmedabad, Gujarat, India (Recruiting)
- Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar — Ahmedabad, Gujarat, India (Recruiting)
- AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East — Dombivli, Maharashtra, India (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, India (Recruiting)
- Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road — Nashik, Maharashtra, India (Recruiting)
- Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar — Nashik, Maharashtra, India (Recruiting)
- Dhanwantri Hospital — Pune, Maharashtra, India (Recruiting)
- Umarji Mother and Child Care Hospital, Balewadi Phata, Baner — Pune, Maharashtra, India (Recruiting)
- Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi — Pune, Maharashtra, India (Recruiting)
- Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East — Vasai, Maharashtra, India (Recruiting)
- Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East — Virār, Maharashtra, India (Recruiting)
- Janta Hospital & Maternity Centre — Varanasi, Uttar Pradesh, India (Recruiting)
- Tulsi Hospital — Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr. Shalini Srivastava, MBBS, MD
- Email: shalini.s@vediclifesciences.com
- Phone: 42172300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.