STUDY PROTOCOL article
Front. Neurol.
Sec. Headache and Neurogenic Pain
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1643130
This article is part of the Research TopicNovel Pharmacological Approaches in Migraine TherapyView all 5 articles
Sishun Formula for acute migraine attack: study protocol for a double-blind, randomized, placebo-controlled trial
Provisionally accepted
- 1Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China
- 2Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China
- 3China Academy of Chinese Medical Sciences Xiyuan Hospital, Beijing, China
- 4Beijing University of Chinese Medicine, Beijing, China
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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 administered within 0.5 hours of migraine onset. The primary outcome is the proportion achieving headache freedom at 2 hours post-dose. Secondary outcomes include the proportion achieving headache relief at 2 hours post-dose, absence of most bothersome associated symptoms, sustained relief/freedom at 24/48 hours, 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. Conclusion: The findings are anticipated to deliver high-quality evidence validating SSF's efficacy and safety, offering a promising therapeutic alternative for acute migraine attacks. Registration details: This study was registered at the International Traditional Medicine Clinical Trial Registry (ITMCTR) under registration number
Keywords: Sishun Formula, acute migraine attack, randomized controlled trial, studyprotocol, Traditional Chinese Medicine
Received: 08 Jun 2025; Accepted: 15 Oct 2025.
Copyright: © 2025 Xuran, Liu, Li, Zhou, Wang, Li, Wu and Cao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Kegang Cao, bucm123@126.com
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