KCT0007272尚未招募未知
Randomized Controlled Study to Evaluate Safety and Efficacy of Banhahubaktang in Patients with Depression
Kyung Hee University Oriental Medical Center0 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1. K-HDRS score of 18 or higher
- •2. Men and women between the ages of 19 and 65
- •3. Volunteered to participate and signed the consent form
- •4. Diagnosed with major depressive disorder of DSM-V
排除标准
- •1. At risk of suicide
- •2. K-HDRS score of 27 or higher
- •3. Diagnosed with major depressive disorder who require hospitalization
- •4. Patients who have received electrotherapy, vagus nerve stimulation, deep brain stimulation, phototherapy, transcranial magnetic stimulation, or psychotherapy within the past 3 months
- •5. Panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, antisocial personality disorder, borderline personality disorder, theatrical personality disorder, or other severe personality disorder (paranoid, schizoid, narcissistic, avoidant, dependent personality disorder, etc.)
- •6. Manic episodes, hypomanic episodes, or mixed episodes
- •7. Abuse/dependence on alcohol or other substances
- •8. Use of substances or drugs that can affect the severity of depression (eg, anti-anxiety drugs, antidepressants, antipsychotics, corticosteroids, female hormones, L-dopa, Digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine, etc. that are being administered alone or as multiple (combination therapy) (except when 4 weeks have elapsed since the last dose of the drug at the time of screening)
- •9. Use of a thrombolytic or anticoagulant
- •10. Medical conditions that may affect the severity of depressive symptoms (e.g., myocardial infarction, arrhythmia, brain tumor, multiple sclerosis, pancreatic disease, hypothyroidism/hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatism) Arthritis, cancer, cerebrovascular disease, dementia, epilepsy, etc.)
- •11. Chronic diseases that are not well controlled despite appropriate treatment (chronic active hepatitis, high blood pressure, diabetes, etc.), Poorly controlled hypertension refers to a condition in which blood pressure is not controlled below 140/90 mmHg even after three or more antihypertensive drugs have been administered in sufficient dose and combination of appropriate drugs including diuretics. It refers to a state in which HbA1c = 9.0% is maintained despite the combination of and administration at a sufficient dose.
- •12. Being treated for liver cancer, cirrhosis, chronic renal failure, etc. or are being treated for congestive heart failure classified as NYHA Class III-IV
- •13. Hepatic and renal dysfunction (at screening, ALT, AST, ALP = 2 times the upper limit of normal or creatinine > 2.0 mg/dL)
- •14. Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •15. A disease that may affect drug absorption or have digestive problems after related surgery
- •16. Enrollment in another clinical trial within 1 month before the start of the study
- •17. Hypersensitivity or allergy to research-related drugs
- •18. Use of herbal medicines or herbal preparations other than this investigational drug
- •19. Those who do not understand the consent form or have difficulty in continuing research due to mental retardation or intellectual problems
- •20. Pregnant or lactating women
- •21. Those who are pregnant and do not agree to the accepted contraceptive methods (dual contraception*, intrauterine contraceptive device and spermicide) during the clinical trial period
- •*Double contraception refers to the case of using hepatic contraception (condoms, diaphragm, etc.) together with other contraceptive methods (sterilization, intrauterine contraceptive device, contraceptive cream, jelly or foam, etc.).
- •22. In case the investigator is determine inappropriate to participate in the clinical trial due to other reasons
研究者
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