A study to evaluate the efficacy of Investigational product on upper respiratory tract health status in healthy adults

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male and female individuals more than equal to 18 and less than equal to 50 years old with moderate physical activity level as per International Physical Activity Questionnaire Short Form (IPAQ - SF)

2. BMI more than equal to 18.5 and less than equal to 34.9 kg per m2

3. High susceptibility to URTIs (more than equal to 3 and less than equal to 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 more than equal to 126 mg/dL

8. Individuals with uncontrolled hypertension on medication and with systolic blood pressure more than equal to 160 and/or diastolic blood pressure more than equal to 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

a) Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence.

b) 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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess effect of the 180 days’ administration of the Investigational Product (IP) on the severity of Upper Respiratory Tract Infection symptoms as assessed by area under the curve (AUC) for Wisconsin Upper Respiratory Symptom Survey 21 (WURSS 21) symptom severity score.Timepoint: 180 Days

Secondary Outcome Measures