| Eligibility |
Inclusion Criteria:
1. Males and females aged =18 to = 50 years.
2. High susceptibility to URTIs, defined as = 4 URTI episodes within 12 months.
3. Presence of an active URTI episode (Defined as a score of =5 for atleast 2 of
following 6 symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy
throat, or cough on the WURSS-21 assessment), with onset of symptoms within 48 hours
prior to screening.
4. SpO2 = 96% as assessed by fingertip pulse oximetry
5. Commitment to adhere to former diet and physical activities throughout the study
period. 6. Able to comply and perform the procedures requested by the protocol
(consumption of study medications, filling daily eDiary for health updates, biological
sample collection procedures and study visit schedule) 7. Participants who are
literate enough to understand the essence of study, are informed about the purpose of
the study, and understand their rights. 8. Participants who are able to give written
informed consent and are willing to participate in the study.
Exclusion Criteria:
1. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal
reconstructive surgery, etc.
2. Clinical signs or Symptoms indicating lower respiratory tract infection.
3. Known sensitivity to the investigational product or any excipients of the drug
product.
4. Any clinically significant abnormalities of the upper respiratory tract (such as
stridor, laryngomalacia, etc.)
5. Any clinically significant acute or chronic respiratory illness (such as Sinusitis,
pharyngitis/tonsillitis, etc.)
6. Chronic cough of any origin not accompanied to other symptoms of URTI
7. Unable to abstain from any home-based remedies for common cold such as steam
inhalation, decoctions, vapour rub, etc. throughout the study period.
8. Presence of uncontrolled type 2 diabetes (Indicated by fasting blood glucose (FBG)
=126 mg/dL)
9. Presence of uncontrolled hypertension (Defined as Systolic Blood Pressure (SBP) = 140
mm Hg and/or Diastolic Blood Pressure (DBP) = 90 mm Hg).
10. Participants with abnormal liver and kidney function tests, defined as:
- Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) levels >
1.5 × upper level of normal
- Serum alkaline phosphatase (ALP) levels > 1.5 × upper level of normal
- Serum creatinine levels > 1.5 × upper level of normal
11. Unable to abstain from ginger, avocado, soy or other known dietary supplements for
common cold throughout the study period.
12. Vaccination against influenza or swine flu within 3 months prior to screening.
13. Those who have taken or will be taking or are taking antibiotics, antivirals,
steroids, nasal decongestants, antihistamines, or other medications that are expected
to alleviate cold symptoms within two weeks prior to randomization.
14. History of any significant neurological and psychiatric condition which may affect the
participation and inference of the study's end points.
15. Individuals having a history (in past 2 years) of smoking or currently smoking or
using any form of smokeless tobacco.
16. Participation in other clinical trials in last 90 days prior to screening
17. Participants with heavy alcohol consumption, defined as
- For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a
day.
- For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standard
alcoholic drink contains approximately 14 grams of alcohol, which is equivalent
to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5
ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or
port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
18. Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a
2-hour time frame.
19. History or presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection.
20. Participants 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.)
21. Females who are pregnant/planning to be pregnant/lactating or taking any oral
contraceptives.
22. 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.
|
