Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Test product (Koff-N-Cold): 2 tablets twice daily for 3 days followed by 1 tablet twice
daily for next 7 days
Control Intervention1: Antihistamine Levocetirizine (5mg) +
Phenylephrine
Sponsors
GREENSPACE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteer aged between 18 to 65 years (both inclusive). 2. Subjects who are willing to give consent. 3. Subjects with Seasonal cough and cold. 4. Subjects with allergic rhinitis. 5. Subjects with running nose and low grade fever.
Exclusion criteria
Exclusion criteria: 1. Patients with pre existing severe systemic disease necessitating long term medication. 2. Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation. 3. Any oncology neurological (congenital or acquired) vascular or systemic disorder which could affect any of the efficacy assessments. 4. Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month. 5. Individuals unable to understand or comply with study protocols due to psychiatric or cognitive challenges. 6. History of allergic reactions to components of the study interventions or procedures. 7. Individuals with significant medical conditions such as cardiovascular diseases uncontrolled diabetes or immunosuppressive disorders. 8. Pregnant or breastfeeding individuals should be excluded if applicable. 9. Participants with chronic infections such as TB Pneumonitis Bronchitis etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate changes in the severity of allergic rhinitis and Acute Respiratory fections (ARIs), acute cough, cold, sneezing, running nose and low-grade fever from the baseline visit to day 10, using Symptomatic Questionnaires and assessing biomarkers such as IgE, CRP. These changes will be compared to the efficacy of available market antihistaminesTimepoint: Day 0, Day 5, Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the safety of the GREENSPACE Koff-N-Cold tablets by hematology Screening on Day0 and Day 10 and also by continuously monitoring any adverse effects or health concerns at all the visits. 2. To evaluate the impact of the tablet by quality-of-life questionnaires. Day - 0, 10.Timepoint: Day 0, Day 10 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd.
Outcome results
None listed