Sishun Formula for acute migraine attack: study protocol for a double-blind, randomized, placebo-controlled trial.

ABSTRACT:

Purpose

Migraine, a leading global cause of disability, affects over 1.1 billion individuals worldwide. Current acute pharmacotherapy is limited by contraindications and adverse events (AEs), underscoring the need for safer, more effective alternatives. The Sishun Formula (SSF), a traditional Chinese medicine (TCM) formulation targeting "Ying-Wei disharmony," demonstrated promising preclinical and preliminary clinical results. This trial aims to rigorously evaluate SSF's efficacy and safety for acute migraine attacks.

Patients and methods

This multicenter, randomized, double-blind, placebo-controlled trial will enroll 144 participants with acute migraine and "Ying-Wei disharmony" syndrome, randomized 1:1 to SSF or placebo. A single dose of SSF or a matched placebo is adminis

SUBMITTER: Zhang X 

PROVIDER: S-EPMC12631295 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature