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

Launched by VEDIC LIFESCIENCES PVT. LTD. · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called EQ-778 to see if it helps improve upper respiratory tract health in healthy adults. It will last for 180 days and involves participants taking either the study medication or a placebo, which is a harmless substance that looks the same but has no active ingredients. The study is currently recruiting participants aged 18 to 50 who are generally healthy but have had multiple upper respiratory infections in the past year. To join, individuals need to be physically active and agree to follow a regular diet and exercise routine during the study.

Participants will be asked to complete questionnaires and attend regular visits throughout the trial. However, some people may not qualify if they have certain medical conditions, such as serious respiratory illnesses or if they are currently taking medications that could interfere with the study. It is important for potential participants to understand that they will need to avoid using home remedies for colds during the trial. This study aims to gather information to determine whether EQ-778 could be a beneficial treatment for preventing upper respiratory infections.

Gender

ALL

Eligibility 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.