Randomized double blind placebo controlled multicentric clinical trial of Ayush M-3 in the management of migraine- A study protocol.

BACKGROUND

Migraine is acknowledged as an intricate and incapacitating neurological malady, profoundly exerting a potent influence on the health-related quality of life of patients causing disability, and augmented burden on families, and entire communities. Notwithstanding the strides made in the field of headache disorder management, there remains a cohort of migraine-afflicted patients who do not encounter satisfactory alleviation. This emphasizes the need for alternative systems in addressing the issue and there is a growing interest in exploring Indian system of medicine to address migraine symptoms.

OBJECTIVE

Due to the dearth of prospective, high-quality randomized controlled trials, this protocol aims to conduct a scientific study of the polyherbal formulation 'Ayush M3' to assess its safety and efficacy in patients suffering with migraine.

MATERIALS AND

METHODS

A prospective, randomized, double blind, parallel-group, placebo controlled, multi - centric, two-arm, exploratory study has been designed to enrol a total of 360 patients at three sites. Migraine patients with or without aura diagnosed as per International Headache Society-ICHD-III below Grade III of MIDAS will be randomized in a 1:1 ratio and administered the trial drug, Ayush M - 3 or placebo for twice a day after food for 16 weeks.

OUTCOME MEASURES: The primary outcomes measures for the study will be changes in the character of disease in terms of frequency, intensity of headache as per VAS (0-10) and duration of episode of headache. Secondary outcome measure will be changes in MIDAS, MSQ2.1, changes in associated symptoms of migraine, change in the use of analgesics/symptom alleviating medication & Change in the required dose/withdrawal of Anti-hypertensive drugs if any. Assessment will be conducted on an interval of 28 days till 16 weeks and an intervention free follow up at the end of week 20.