Study protocol for a randomized, triple-blind, placebo-controlled trial of modified Ukgan-san in patients with Hwabyung and neurotic symptoms - Report - MDSpire
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Protocol for a Randomized, Triple-Blind, Placebo-Controlled Trial Assessing Modified Ukgan-san in Individuals with Hwabyung and Associated Neurotic Symptoms
Clinical Report: Protocol for a Randomized Trial on Modified Ukgan-san for Hwabyung
Background
Hwabyung is a culture-related anger syndrome prevalent in East Asian contexts, particularly Korea, characterized by suppressed anger and various somatic symptoms. It is recognized in clinical practice guidelines, and modified Ukgan-san is widely prescribed for neurotic symptoms and anger-related manifestations.
Data Highlights
No numerical data is provided in the source material.
Key Findings
The trial will recruit 104 adult participants diagnosed with Hwabyung and neurotic symptoms.
Participants will be randomly assigned to receive either modified Ukgan-san or a placebo in a 1:1 ratio.
The intervention will be administered thrice daily for 4 weeks.
Primary outcome measures include changes in Hwabyung symptom severity using a validated scale.
Secondary outcomes will assess anger, depression, anxiety, neurotic symptoms, and heart rate variability.
Data analysis will utilize linear mixed models based on the intention-to-treat principle.
Clinical Implications
The study's design emphasizes the importance of rigorous evaluation in herbal treatments for neurotic symptoms.
Conclusion
This trial aims to generate evidence regarding the efficacy and safety of modified Ukgan-san in patients with Hwabyung.
