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

Effect of Huanglian-jie-du decoction for somatic symptoms and insomnia in patients with Hwa-byung: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002379

Enrollment

Registered

2017-07-20

Start date

2017-07-10

Completion date

Unknown

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental group: Huanglian-jie-du decoction (HJD) 2.5g per time orally 3 times per day for 7 days. Control group: placebo(identical to the study drug in appearance, smell, and taste) 2.5g pe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Patient Health Questionnaire Physical Symptoms (PHQ-15);Insomnia Severity Index(ISI)	—

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactYujin Choi

Kyung Hee University Oriental Medical Center

Outcome results