None listed
Conditions
Interventions
Intervention1: EQ-778: 1 capsule daily after breakfast (in case of no URTI episode)for 180 days
2 capsules after breakfast (in case of URTI episode) till end of episode
Control Intervention1: Placebo: 1 capsule daily after breakfast (in case of no URTI episode)for 180 days
2 capsules after breakfast (in case of URTI episode) till end of episode
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the effect of the IP as compared to placebo from baseline on Nasal Viral load as assessed by TRU-PCR analysisTimepoint: During Upper respiratory tract infection episodes;To evaluate the effect of the IP as compared to placebo from baseline on Change in frequency of current URTI episodes rates as compared to the self-reported historical frequency of URTI in previous 6 months before study beginsTimepoint: Day 180;To evaluate the effect of the IP as compared to placebo from baseline on Change in participants URTI symptoms severity as compared to the previous dayTimepoint: During Upper respiratory tract infection episode;To evaluate the effect of the IP as compared to placebo from baseline on change in quality of life using the WURSS-21 questionnaire (in eDiary, as and when the subject gets an episode – recall period: last 24 hours)Timepoint: Throughout the study period (180 Days);To evaluate the effect of the IP as compared to placebo from baseline on General fatigue as assessed by Fatigue Severity Scale (FSS)Timepoint: Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180;To evaluate the effect of the IP as compared to placebo from baseline on Immunity as assessed by the change in salivary IgA from baselineTimepoint: Day 180;To evaluate the effect of the IP as compared to placebo from baseline on Mood as assessed by Visual Analogue Scale (VAS)Timepoint: During Upper respiratory tract infection episodes;To evaluate the effect of the IP as compared to placebo from baseline on percentage of population suffering having one or more episode of URTIs during study.Timepoint: Day 180;To evaluate the effect of the IP as compared to placebo from baseline on Sleep quality assessed by Pittsburgh Sleep Quality IndexTimepoint: Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180;To evaluate the effect of the IP as compared to placebo from baseline on Stress measured by Perceived Stress Scale (PSS)Timepoint: Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180;To evaluate | — |
Countries
India
Contacts
Public ContactDr Sonal Raote
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed