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Study protocol for a randomized, triple-blind, placebo-controlled trial of modified Ukgan-san in patients with
Hui-Yeong Park1, Seok-In Yoon1, Yerim Jeon2
1Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Background:
Hwabyung is a culture-related anger syndrome characterized by chronically suppressed anger and somato-emotional symptoms. Modified Ukgan-san is widely prescribed for neurotic symptoms; moreover, it is recommended for anger-related manifestations in the clinical practice guidelines for Hwabyung. However, no randomized controlled trials evaluating its efficacy in patients with Hwabyung are currently available. This study aims to investigate the efficacy and safety of modified Ukgan-san in patients with Hwabyung presenting with neurotic symptoms.
Methods:
This will be a single-center, randomized, placebo-controlled, triple-blind, two-arm, parallel clinical trial. A total of 104 adult participants diagnosed with Hwabyung and presenting with neurotic symptoms will be recruited and randomly assigned in a 1:1 ratio to receive modified Ukgan-san extract granules or placebo. The intervention will be administered thrice daily for 4 weeks. The primary outcome is the change in Hwabyung symptom severity, measured using a validated self-report Hwabyung Scale. Secondary outcomes include anger, depression, anxiety, neurotic symptom-related indices, and heart rate variability. Assessments will be conducted at baseline and at weeks 2, 4, and 8. Data will be analyzed using linear mixed models according to the intention-to-treat principle.
Discussion:
We believe this trial will provide high-quality evidence on the effectiveness and safety of modified Ukgan-san in patients with Hwabyung and neurotic symptoms, addressing the gap between clinical recommendations and controlled trial evidence.
Ethics And Dissemination:
This study was approved by the Institutional Review Board of Kyung-Hee University Oriental Medicine Hospital in Gangdong (KHNMCOH 2025-10-001-001). The results will be disseminated through publication in peer-reviewed journals.
Trial Registration:
This study was registered with the Clinical Research Information Service (CRIS), Republic of Korea (No. KCT0011347; December 18, 2025).