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NCT07068815
Efficacy and Mechanism of Fu's Subcutaneous Needling Treatment for Migraine Without Aura
Phase 1 trial testing Fu's Subcutaneous Needling in Migraine Without Aura in 60 participants. Not yet recruiting.
1 March 2027
Quick facts
| Lead sponsor | Guangzhou University of Chinese Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 September 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 June 2027 |
Drugs / interventions tested
- Fu's Subcutaneous Needling
- Flunarizine Hydrochloride — full drug profile →
Conditions studied
- Migraine Without Aura — all drugs for Migraine Without Aura →
Sponsor
Guangzhou University of Chinese Medicine
Who can join
Adults 18 to 65, any sex, with Migraine Without Aura. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Fu's Subcutaneous Needling treatment for migraine without aura: a randomized controlled trial protocol.
Guo W, Yang Y, Sun J. · · 2025 · PMID 41603007 · DOI 10.3389/fneur.2025.1689562
Verify or expand the search:
- PubMed search for NCT07068815
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Migraine Without Aura
Currently open trials in the same condition.
- NCT05889624 — Responding With Evidence and Access for Childhood Headaches · NA · recruiting
- NCT05903027 — Gepant treAtments: EffectIveNess and tolERability (GAINER) · recruiting
- NCT05484349 — TIzanidine for the Preventive Treatment of Episodic MigrainE （TIME） · Phase 3 · recruiting
- NCT04715685 — Mind Body Balance for Pediatric Migraine · NA · recruiting
Other Guangzhou University of Chinese Medicine trials
Trials by the same sponsor.
- NCT07161427 — Fu's Subcutaneous Needling for Postacute Lateral Ankle Sprain and Prevention of Chronic Ankle Instability · NA · not yet recruiting
- NCT06315101 — Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellul · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07068815 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangzhou University of Chinese Medicine
- Last refreshed: 16 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07068815.
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