To Evaluate efficacy and tolerability of Vasograin ( Ergotamine 1 mg plus Paracetamol 250 mg plus Prochlorperazine 2.5 mg plus Caffeine 100 mg) in adult patients in the treatment of acute migraine: An Open label, Non-randomized, Single arm Clinical Trial

This study aims to evaluate the effectiveness and safety of Vasograin, a combination medication (Ergotamine 1 mg, Paracetamol 250 mg, Prochlorperazine 2.5 mg, Caffeine 100 mg), in treating acute migraines in adults. It will be conducted as an open-label, non-randomized, single-arm clinical trial, the study will include 1000 patients. Eligible participants are adults aged 18 or older, experiencing migraine headaches as diagnosed by a physician, and capable of understanding and consenting to the study. Exclusion criteria include allergies to the study drugs, significant liver or kidney disease, and women who are pregnant, breastfeeding, or using oral contraceptives.

The primary objective is to assess the efficacy of Vasograin in relieving migraine pain, measured by the proportion of patients reporting no headache pain at 2 and 4 hours post-dose, using a 4-point Likert scale. Secondary objectives include evaluating pain intensity reduction at 4 hours, the proportion of patients achieving sustained pain-free intervals (24 and 48 hours), the need for rescue medication within 24 hours, and relief from associated symptoms such as nausea, vomiting, photophobia, and phonophobia at 2 and 4 hours. This comprehensive evaluation aims to determine if Vasograin is an effective and tolerable treatment option for adults suffering from acute migraines.