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Study to Evaluate Safety and Efficacy of Yukwool-tang(LIUYU-tang) for Major Depression of women

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Yukwool-tang(LIUYU-tang) for Major Depression of women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002532
Enrollment
72
Registered
2017-11-10
Start date
2017-10-16
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

None listed

Interventions

Drug : 1. Yukwool-tang(LIUYU-tang) Atractylodes japonica, Citrus reticulata, Cnidium officinale Makino, Poncirus trifoliata, Forsythia koreana, Cyperus rotundus, Fritillaria ussuriensis, Gardenia jasm

Sponsors

Daejeon Korean Medicine Hospital of Daejeon University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Women aged 20 to 65 years 2) Those diagnosed with Diagnostic and Statistical Manual of Mental Disorders-Fifth edition major depression 3) Those with a Korean Hamilton Depression Rating Scale score of 14 or higher 4) who has voluntarily participated and signed the agreement

Exclusion criteria

Exclusion criteria: 1) Those who are at risk of suicide 2) Persons with psychotic features such as delusions, hallucinations, or history 3) A man with a history of manic, schizophrenic, and mixed artworks 4) Alcohol or other substances Abuse / Dependence or history 5) Those who have had acute and chronic infectious diseases for the last 2 weeks 6) Patients who are taking drugs or substances that may affect the degree of depression (eg anxiolytics, antidepressants, antipsychotics, corticosteroids, female hormones, L-dopa, Digitalis, bromide, cyclosporin, disulfiram , Isoniazid, yohimbine, etc.) 7) People with a medical condition that may affect the degree of depression (eg, myocardial infarction, brain tumor, multiple sclerosis, hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatoid arthritis, Vascular disease, epilepsy, etc.) 8) Those with chronic diseases that are not well controlled by appropriate treatment (chronic active hepatitis, hypertension, diabetes, etc.) 9) Those who are treated with liver cancer or liver cirrhosis, chronic kidney failure, congestive heart failure, etc. 10) Creatinine clearance calculated by the cockcroft-Gault formula for renal patients is less than 50 ml / min 11) Those who have a disease that may affect the absorption of the drug or who have digestive disturbance after the related surgery 12) Those who participated in other clinical trials with interventions within one month before the start of the study 13) People who have hypersensitivity to research-related drugs and allergy history 14) Those who are unable to understand the consent form due to mental retardation or intellectual problems 15) Pregnant or lactating women 16) Those who do not consent to the approved method of contraception during the clinical trial (double condom *, oral or parenteral hormone contraceptive, intrauterine contraceptive, and spermicide) * Double contraception refers to the use of other contraceptive methods (such as infertility surgery, intrauterine contraceptive, oral contraceptive, other hormonal delivery system, pessary cream, jelly or foam) in conjunction with condom contraception (condoms, diaphragm, etc.). 17) If the subject is found to be inappropriate for participation in clinical trials due to other reasons

Design outcomes

Primary

MeasureTime frame
The Korean Hamilton Depression Rating Scale(K-HDRS)

Secondary

MeasureTime frame
The Korean version of the Beck Depression Inventory(BDI-K);Instrument on Pattern Identification for Depression;Beck Hopelessness Scale;Korean Symptom Checklist-95 (KSCL-95);Insomnia Severity Index (ISI);State-Trait Anxiety Inventory;EuroQol-5 dimension (EQ-5D);visual analogue scale;Emotional Stimulus Test;Brain-derived neurotrophic factor (BDNF);Inflammatory cytokines and tumor necrosis factor (IL-1ß, IL-2, IL-4, IL-6, IL-10, TNF-a, IFN-?, TGF-ß1);Depression-related genetic polymorphism & Epigenetic test (SLC6A4, SLC6A3, SLC1A1, GAD1, NR2A, NRG1, TPH2, GRM7, OXTR, AVPR1A, MGLUR5, COMT, BDNF, IL6, IL1beta);microbiome;Adverse reaction;Epigenetic test (SLC6A4, BDNF, OXTR)

Countries

Korea, Republic of

Contacts

Public ContactKim hwan

Dunsan Korean Medicine Hospital of Daejeon University

yellow0121@naver.com+82-42-470-9561

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026