Study protocol for a randomized, triple-blind, placebo-controlled trial of modified Ukgan-san in patients with Hwabyung and neurotic symptoms - Scorecard - MDSpire
Advertisement
Protocol for a Randomized, Triple-Blind, Placebo-Controlled Trial Assessing Modified Ukgan-san in Individuals with Hwabyung and Associated Neurotic Symptoms
Clinical Scorecard: Protocol for a Randomized, Triple-Blind, Placebo-Controlled Trial Assessing Modified Ukgan-san in Individuals with Hwabyung and Associated Neurotic Symptoms
At a Glance
Category
Detail
Condition
Hwabyung
Key Mechanisms
Modified Ukgan-san is used for neurotic symptoms and anger-related manifestations.
Target Population
Adults diagnosed with Hwabyung presenting with neurotic symptoms.
Care Setting
Single-center clinical trial.
Key Highlights
Study investigates efficacy and safety of modified Ukgan-san.
Participants will be randomly assigned to receive either modified Ukgan-san or placebo.
Primary outcome is change in Hwabyung symptom severity.
Secondary outcomes include measures of anger, depression, anxiety, and heart rate variability.
Trial registered with Clinical Research Information Service (CRIS), Republic of Korea.
Guideline-Based Recommendations
Diagnosis
Hwabyung is classified under code U22.2 in the Korean Standard Classification of Diseases.
Management
Korean Medicine Clinical Practice Guidelines recommend Ukgan-san for anger-related symptoms.
Monitoring & Follow-up
Assessments will be conducted at baseline and at weeks 2, 4, and 8.
Risks
No specific risks mentioned; safety will be assessed during the trial.
Patient & Prescribing Data
104 adult participants diagnosed with Hwabyung.
Modified Ukgan-san extract granules administered thrice daily for 4 weeks.
Clinical Best Practices
Use validated self-report Hwabyung Scale for symptom severity assessment.
Follow intention-to-treat principle for data analysis.
