Effect of Cephagraine Tablets and Nasal Drops in Patients with Migraine and Sinusitis‑Related Headache: An Open‑Label Clinical Trial

Background: Headache disorders, particularly migraine and sinusitis‑related headache, are among the leading causes of disability worldwide. Misclassification between these conditions is common, often resulting in inappropriate therapy. Cephagraine, a polyherbal formulation available as tablets and nasal drops, contains herbs with anti‑inflammatory, analgesic, mucolytic, and neuroprotective properties. This study evaluated its efficacy in reducing headache severity and improving quality of life in patients with migraine or sinusitis‑related headache. Methods: A prospective, interventional trial, open‑label, multi‑center trial enrolled 300 adults (aged 18–60 years), with 150 diagnosed with migraine (ICHD‑3 criteria) and 150 with sinusitis‑related headache (ENT examination using symptom‑based criteria). Participants received Cephagraine tablets (215 mg*2- thrice daily) and nasal drops (two drops per nostril thrice daily) for 15 days. Outcomes were assessed at baseline, Day 8, and Day 15 using validated scales: VAS, MIDAS, HIT‑6 for migraine; SNOT‑22, NOSE, VAS for sinusitis. Statistical analysis employed paired t‑tests, Wilcoxon signed‑rank tests, and ANOVA. Results: Both groups demonstrated significant reductions in headache severity. VAS scores decreased from 7.8 to 2.6 in migraine patients and from 7.5 to 2.9 in sinusitis patients (p < 0.001). MIDAS scores reduced by 55.4%, while SNOT‑22 scores decreased by 52.8%. Frequency of headache episodes dropped by over 50% in both groups. Quality‑of‑life measures improved significantly (HIT‑6 reduction: 11.9 points; NOSE reduction: 33.8 points). Patient‑reported global improvement was high, with 82% of migraine and 78% of sinusitis patients reporting marked relief. Safety was favorable, with only mild nasal irritation in 6% of participants and >90% compliance. Conclusion: Cephagraine tablets and nasal drops significantly reduced headache severity, frequency, and disability in both migraine and sinusitis patients, with strong safety and adherence profiles. These findings support Cephagraine’s dual‑action utility in managing overlapping headache presentations.