Efficacy and safety of Koff-N-Cold tablets in patients with allergic rhinitis or seasonal cough and cold: a prospective, randomized, open label, two-arm clinical trial

Background: Koff-N-Cold is a proprietary polyherbal formulation developed to target both allergic and anti-inflammatory conditions. The objective of this study is to evaluate the efficacy and safety of Koff-N-Cold tablets compared with standard antihistamine therapy in adults with allergic rhinitis or seasonal cough and cold. Methods: This study is a prospective, randomized, open-label, two-arm clinical trial. Sixty adult subjects (18-65 years) with allergic rhinitis or seasonal cough and cold were randomized in a 1:1 ratio to receive standard therapy [combination of levocetirizine (5 mg) and phenylephrine (5 mg)] for 5 days and Koff-N-Cold tablets for up to 10 days. Efficacy was assessed using symptom severity questionnaires and allergen-specific and anti-inflammatory biomarkers such as serum immunoglobulin E (IgE) and C-reactive protein (CRP) at baseline and Day 10. Safety was evaluated through adverse event monitoring, vital signs, and hematological parameters. Results: Both treatment groups showed significant improvement in symptom scores from baseline to Day 10. The Koff-N-Cold group showed marked reduction in total symptom scores, serum IgE, and CRP levels by Day 10, therefore achieving improvements greater than the standard levocetirizine and phenylephrine. No adverse events or clinically significant laboratory abnormalities were reported in either group. Conclusions: Koff-N-Cold tablets were safe and effective in reducing symptoms and inflammatory markers associated with allergic rhinitis and seasonal cough and cold. The findings support Koff-N-Cold as a well-tolerated, evidence-based herbal alternative to conventional antihistamine therapy. Trial registration: Trial registration number: CTRI/2025/07/092048