None listed
Conditions
Interventions
Drug : 1. Experimental group (GGBT group): Gamiguibi-tang Administration + Usual Care
-Gamiguibi-tang Administration: Kracie Gamiguibi-tang Extract Fine Granule (Orally administered, morning and even
Sponsors
Woosuk University Korean Medicine Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 19 to 45 years 2) Postpartum women between 8 weeks (56 days) and 1 year (365 days) after live birth 3) Total score of =5 on the Generalized Anxiety Disorder-7 (GAD-7) 4) Total score of =7 on the Edinburgh Postnatal Depression Scale (EPDS) 5) Voluntary provision of written informed consent to participate in the trial
Exclusion criteria
Exclusion criteria: 1) History of major psychiatric disorders within the past 2 years 2) History of taking psychotropic medications (antipsychotics, antidepressants, mood stabilizers) within the past 2 years 3) History of suicide/self-harm attempts or judged by the investigator to be at risk for suicide/self-harm 4) Current thyroid disease or abnormal thyroid function test results at screening (TSH =0.3 µIU/mL or TSH =6.8 µIU/mL) 5) Severe hepatic or renal impairment, or at screening: AST or ALT =2 times the upper limit of normal (ULN), BUN =2 times ULN, or creatinine =2.0 mg/dL 6) Diagnosis of malignant tumor within the past 5 years 7) Uncontrolled hypertension (systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg at screening) 8) Uncontrolled diabetes mellitus (HbA1c =9% at screening) 9) Other serious uncontrolled cardiovascular, respiratory, gastrointestinal, genitourinary, neuropsychiatric, hematologic, endocrine, autoimmune, or infectious diseases 10) Currently pregnant 11) Not using medically acceptable contraceptive methods during the trial period 12) History of significant alcohol or substance abuse 13) Galactose intolerance, Lapp lactase deficiency, or known hypersensitivity to the investigational product 14) Participation in another clinical trial and administration of investigational product within 3 months prior to screening 15) Any other condition that, in the investigator's judgment, would make participation in the trial inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total score of Generalized Anxiety Disorder-7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Perceived Stress Scale;Insomnia Severity Index;Edinburgh Postnatal Depression Scale;Patient Health Questionnaire-9 (PHQ-9);EQ-5D-5L;Patients’ Global Impression of Change | — |
Countries
Korea, Republic of
Contacts
Public ContactEun-Hee Lee
Woosuk University
Outcome results
None listed