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Journal of Traditional Chinese Medicine >

2026 , Vol. 46 >Issue 4: 941 - 950

DOI: https://doi.org/10.19852/j.cnki.jtcm.2026.04.014

Original Articles

Efficacy and safety of Dingluo nasal drops (丁萝滴鼻剂) for the acute treatment of migraine: a pilot randomized trial

  • YAO Yuning ,
  • AN Yuqiu ,
  • LIU Jiaojiao ,
  • DU Boxuan ,
  • CAO Kegang
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  • Department of Neurology, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100007, China

Received date: 2025-02-11

  Accepted date: 2025-10-16

  Online published: 2026-08-08

Supported by

2022 Young Qihuang Scholars Training Program: Letter of Chinese Medicine Education([2022] 256);National Natural Science Foundation of China: Study on the Mechanism of the Treatment Method to Open the Oriffces and Alleviate Pain in Regulating G Protein-coupled Estrogen Receptor (GPER) to Antagonize Calcitonin Gene-related Peptide Receptors in Acute Migraine(82505542);Joint Program of Liaoning Provincial Science and Technology Plan (General Program of Natural Science Foundation): Study on the Mechanism of Dinglu Nasal Drops in Treating Acute Migraine Mediated by GPER-mitogen-activated Protein Kinase/Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Signaling Pathway(2024-MSLH-530)

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Abstract

OBJECTIVE: To evaluate the efficacy and safety of two doses of Dingluo nasal drops (丁萝滴鼻剂) compared to placebo in the acute treatment of migraine.

METHODS: This randomized, parallel-treatment, placebo-controlled, double-blind trial was conducted at Dongzhimen hospital, Beijing University of Chinese Medicine. Eligible participants were randomly assigned (1∶1∶1) to receive either full-dose Dingluo nasal drops, half-dose Dingluo nasal drops, or a placebo for three migraine attacks. The primary endpoint was the proportion of participants achieving pain freedom at 2 h postdose, assessed in all randomly assigned participants who received study medication.

RESULTS: A total of 91 participants with 257 attacks were included in the statistical analysis. At 2 h postdose, Dingluo nasal drops were superior to placebo for freedom from pain [high dose vsplacebo: 14.61% vs1.20%, P = 0.001, risk difference 13.40, 95% CI(5.70, 21.11); low dose vsplacebo: 17.65% vs1.20%, P <0.001, risk difference: 16.44, 95% CI (8.00, 24.88)]. The high dose and the low dose effected similarly for freedom from pain [14.61% vs17.65%, P = 0.585, risk difference: －3.04, 95% CI(－13.97, 7.89)]. It showed a good efficacy in pain relief. The most common adverse events were nasal burning and nasal itchiness. All adverse events are transient and dissipate within a relatively short time frame.

CONCLUSIONS: Dingluo nasal drops demonstrated superior efficacy to placebo in achieving pain freedom for acute migraine treatment. Mild nasal reactions were observed, with a trend toward reduced discomfort at the half-dose concentration.

Key words： migraine disorders; treatment outcome; safety; randomized trial; Dingluo nasal drop

Cite this article

YAO Yuning , AN Yuqiu , LIU Jiaojiao , DU Boxuan , CAO Kegang . Efficacy and safety of Dingluo nasal drops (丁萝滴鼻剂) for the acute treatment of migraine: a pilot randomized trial[J]. Journal of Traditional Chinese Medicine, 2026 , 46(4) : 941 -950 . DOI: 10.19852/j.cnki.jtcm.2026.04.014

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