Efficacy and Safety of Bunsimgieum-gami on Hwa-byung

Efficacy and Safety of Bunsimgieum-gami on Hwa-byung: Randomized, Double-blind, Placebo-controlled, Multi-center Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003263

Enrollment

Registered

2018-10-12

Start date

2018-10-12

Completion date

Unknown

Last updated

2019-03-11

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: Bunsimgieum-gami extract granule 6g per time, orally 3 times (before or between meals) per day, for 8 weeks. Control group: Placebo of Bunsimgieum-gami granule 6g per time,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) aged between 19 and 65 2) diagnosis of Hwa-byung by Hwa-byung Diagnostic Interview Schedule 3) willingness to participate and to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) high risk of suicide 2) current or lifetime severe psychiatric disorders (severe psychiatric disorders mean disorders that produce psychotic symptoms, such as schizophrenia) 3) current of previous intake of antidepressant, anxiolytic, or non-psychopharmacologocal drugs having psychotropic adverse effect within 4 weeks. 4) current or lifetime alcohol or drugs use disorders 5) serious unstable medical condition 6) hyperthyroidism or hypothyroidism 7) alanine aminotransferase and aspartate aminotransferase levels 1.5 times as high as or higher than the normal upper limit 8) blood urea nitrogen and creatinine levels 1.5 times as high as or higher than the normal upper limit 9) uncontrolled diabetes or hypertension 10) pregnancy or likelihood of pregnancy due to lack of proper contraception, or lactation. 11) current of previous intake of other drugs expect hypotensive, hypoglycemic, and antihyperlipidemic agents 12) participated in other clinical trials within 30 days 13) hypersesnsitivity to experimental or placebo medication of this clinical trial

Design outcomes

Primary

Measure	Time frame
Likert Scale for Hwa-byung Symptoms (HB-M)	—

Secondary

Measure	Time frame
Patient Health Questionnaire Physical Symptoms (PHQ-15);Insomnia Severity Index (ISI);Stress Response Inventory (SRI);State-Trait Anger Expression Inventory-State Anger (STAXI-S);Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactYu-Jin Choi

Kyung Hee University Oriental Medical Center

choiyjn01@gmail.com+82-2-958-9188

Outcome results