Objective:

To investigate the efficacy and safety of modified Ukgan-san in patients with Hwabyung presenting with neurotic symptoms.

Approach:

• Study Design: Single-center, randomized, placebo-controlled, triple-blind, two-arm, parallel clinical trial.
• Participants: 104 adult participants diagnosed with Hwabyung and presenting with neurotic symptoms will be recruited.
• Intervention: Participants will be randomly assigned to receive modified Ukgan-san extract granules or placebo, administered thrice daily for 4 weeks.
• Outcomes: Primary outcome: 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: Assessments will be conducted at baseline and at weeks 2, 4, and 8.
• Data Analysis: Data will be analyzed using linear mixed models according to the intention-to-treat principle.

Key Findings:

• No randomized controlled trials evaluating the efficacy of modified Ukgan-san in patients with Hwabyung are currently available.
• The study aims to address the gap between clinical recommendations and controlled trial evidence.

Interpretation:

The trial is expected to provide high-quality evidence on the effectiveness and safety of modified Ukgan-san in patients with Hwabyung and neurotic symptoms.

Limitations:

• The study is limited to a single-center trial.
• Results may not be generalizable beyond the study population.

Conclusion:

The study aims to rigorously evaluate the efficacy of modified Ukgan-san for Hwabyung, contributing to the understanding of anger-related psychopathology.

Sources:

• Clinical Research Information Service