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

Abstract

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.