A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections

Exclusion Criteria

• •1. High grade fever defined as body temperature ≥ 39ºC (≥ 102.2 ºF)
• •2. With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
• •3. Individuals with history of Chronic obstructive pulmonary disease, pulmonary fibrosis or Asthma.
• •4. Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
• •5. Individuals requiring hospitalization or likely to be hospitalised due to URTI.
• •6. Individuals with common cold for the first time.
• •7. Individuals with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
• •8. Individuals with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
• •9. Individuals with history of immunocompromised state immune system with/ without organ transplant
• •10. Individuals with known or suspected hypersensitivity or intolerance to herbal products
• •11. Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetes mellitus, Cystic fibrosis
• •12. Diagnosed cases of Uncontrolled hypertension as assessed by a systolic blood pressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg
• •13. Those not willing to abstain from home based cold remedies that include but are not limited to steam inhalation, decoctions, vapour rub, ginger supplement, decoctions, or any form of dietary and/or herbal supplements during the entirety of study participation period.
• •14. Those who have been vaccinated for influenza, swine flu 3 months prior to screening visit.
• •15. Those who have taken within one week of the start of the study or require during study antibiotics, antivirals, steroids, nasal decongestants, antihistamines herbal remedies, Vitamin C or Zinc to alleviate cold symptoms.
• •16. Those who have severe mental illnesses, such as dementia, Parkinson's disease, Alzheimer's Disease, depression or anxiety disorders, or those who are currently taking psychoneurological drugs, such as antidepressants.
• •17. Those who have participated in other clinical study within 30 days, prior to the screening visit or plan to participate in other clinical study during the study period.
• •18. Individuals with substance abuse as per last two-year history that includes the use of but is not limited to drugs such as cocaine, amphetamine, marijuana etc.
• •19. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
• •20. Individuals with heavy alcohol consumption, defined as:
• •1. For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
• •2. For women: More than 7 SAD/week or more than 3 SAD in a day.
• •3. Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.
• •4. Binge drinkers, defined as 4 or more SAD for Women, in a 2-hour time frame. (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)
• •21. Those who have clinically significant disorder/s of cardiovascular, endocrine, lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervous system, musculoskeletal and digestive systems.
• •22. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
• •23. Any condition that could, in the opinion of the investigator, preclude the individual's ability to successfully and safely complete the study or that may confound study outcomes.