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

TL;DR

This study will test a traditional Chinese medicine formula for treating acute migraines in a clinical trial to see if it is safe and effective.

Contribution

The study introduces a novel clinical trial protocol to evaluate the Sishun Formula as a potential alternative treatment for acute migraines.

Findings

SSF will be tested for headache freedom and relief within 2 hours of administration.

Biomarkers like CGRP and safety parameters will be monitored to assess efficacy and safety.

The trial will provide evidence on SSF's potential as a treatment for 'Ying-Wei disharmony' syndrome in migraines.

Abstract

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.

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 administered within 0.5 h of migraine onset. The primary outcome is the proportion achieving headache freedom at 2 h post-dose. Secondary outcomes include the proportion achieving headache relief at 2 h post-dose, absence of most bothersome associated symptoms, sustained relief/freedom at 24/48 h, the Visual Analogue Scale (VAS) score changes, time to efficacy onset, recurrence rates, and TCM syndrome improvement. Biomarkers [e.g., calcitonin gene-related peptide (CGRP)] and safety parameters (vital signs, laboratory tests, AEs) are monitored. Data analysis will employ SPSS 25.0 and R 4.3.1.

The findings are anticipated to deliver high-quality evidence validating SSF’s efficacy and safety, offering a promising therapeutic alternative for acute migraine attacks.

http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025000187.

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