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

Vedic Lifesciences

Status: Enrolling

Conditions: Upper Respiratory Tract Infection

Treatments: Other: EQ-778; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05835375

PL/221201/EQ/CCI

Details and patient eligibility

About

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

Enrollment: 374 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

374 participants in 2 patient groups, including a placebo group

EQ-778

Active Comparator group

Description:

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)

Treatment:

Other: EQ-778

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo