drugset / Trial / NCT07068815

Efficacy and Mechanism of Fu's Subcutaneous Needling Treatment for Migraine Without Aura

NCT07068815

Phase 1 Not yet recruiting 60 enrolled Guangzhou University of Chinese Medicine
RandomizedParallel-groupTriple-blindTreatment

Summary

This study aimed to compare the analgesic efficacy and quality-of-life improvement between FSN and flunarizine hydrochloride in patients with migraine without aura. The core research questions addressed were: Q1: Whether FSN demonstrates superior or at least equivalent therapeutic effects compared to the active control drug (flunarizine hydrochloride) in pain relief and quality-of-life enhancement for migraine without aura patients; Q2: To elucidate the mechanism of FSN in treating migraine without aura from a cerebral hemodynamic perspective. Participants will:1. Group allocation: A randomized design was employed, with 30 participants enrolled per group. 2. Interventions: Experimental group: Subjected to FSN monotherapy; Control group: Treated with oral flunarizine hydrochloride. 3. Treatment duration: All participants received a 4-week therapeutic intervention. 4. Outcome measures: The following parameters were systematically evaluated during treatment and follow-up: Visual Analog Scale (VAS) scores 、Migraine-Specific Quality of Life (MSQOL) scores、Near-infrared spectroscopy (NIRS) examinations.Researchers will compare FSN to flunarizine hydrochloride(a clinically established medication) to see if FSN exhibits superior or non-inferior efficacy to treat migraine without aura.

Timeline

Start
2025-09-01
Primary completion
2027-03-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Flunarizine Small molecule 5 mg Oral

Indications