Efficacy and safety of Huanglian-jie-du decoction for hwa-byung

Not Applicable

Completed

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0002379
• Lead Sponsor: Kyung Hee University Oriental Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Diagnosis of Hwabyung by Hwabyung Diagnostic Interview Schedule (HBDIS)
2. Presenting within 4 weeks after Hwabyung symptoms onset.
3. No problem on communication.
4. Willingness to participate and to sign the informed consent form.

Exclusion Criteria

1. Patients who are evaluated as high risk of suicide
2. Patients who suffer current or lifetime Bipolar disorder, Schizophrenia
3. Patients who take excluded therapy within these days.
a. take all psychotropic within 30 days on screening day(ex. antidepressant, anxiolytic, antipsychotic)
b. take non-psychopharmacologocal drugs that have psychotropic effect within 14 days on screening day
c. take all psychotherapy within 30 days on screening day
d. take electroshock treatment, transcranial magnetic therapy within 30 days on screening day
e. take all oriental medical treatment for depression within 14 days on screening day
4. Patients who have serious unstable medical condition.
5. Diabetic patients not controlled by hypoglycemic agents or insulin.
6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg.
7. Alanine aminotransferase(ALT) and aspartate aminotransferase(AST) levels 1.5 times as high as or higher than the normal upper limit
8. Blood urea nitrogen (BUN) and creatinine (Cr) levels 1.5 times as high as or higher than the normal upper limit
9. Patients who had abnormality on lab study with Hwabyung (ex. hyperthroidism, hypothyrodism)
10. Women during pregnancy, lactation, or those who are likely to have been pregnant without proper contraception.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire Physical Symptoms (PHQ-15);Insomnia Severity Index(ISI)

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale for Hwabyung Symptoms(VAS-HS);State-Trait Anger Expression Inventory-State Anger(STAXI-S);Stress Response Inventory(SRI);Adverse events