KCT0003811已完成未知
GamiGuipi-Tang for Treating Insomnia Disorder : multi-site, randomized controlled double-blind, comparative clinical trial study
Pusan National University Korean Medicine Hospital0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 96
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
- 18?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1. Male and female candidates aged 19 or older and under 80 years old
- •2. Individuals with an Insomnii Severity Index (ISI) score of 15 or more.
- •3.Those who meet the DSM-5 criteria for diagnosing insomnia
- •4. Those who voluntarily agreed to participate after hearing a sufficient explanation of the purpose and implementation of this clinical trial
排除标准
- •1. Those who vary in the type or capacity of sleeping pills they take regularly to improve their insomnia within the last four weeks.
- •2. Those who have received oriental medicine treatment (e.g., acupuncture, moxibustion and herbal medicine) for the purpose of improving insomnia within the last 4 weeks
- •3. Persons who have started health supplements, or other non-drug treatments (cognitive behavior therapy, meditation, etc.) for the purpose of improving their insomnia within the last four weeks or are planning to start anew during clinical trials
- •4. Those who have been diagnosed with major depression, anxiety disorder, panic disorder, and other mental disorders, or who have been diagnosed with caffeine, alcohol or drug addiction, or those with a anxiety or depression score of 11 or more points in HADS (Hospital Anxiety and Depression Scale).
- •5. Shift shifts that can clearly affect the life cycle, and shift hours during the day.
- •6. A person with a condition that can cause a clear pain or insomnia to disturb to sleep.
- •7. Abnormal hormone levels in thyroid functional assay ( TSH < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
- •8. Patients with clinically significant anomalies in Blood chemistry (SGPT, SGOT: at least two times the upper limit, serum creatinine: 1.5 times the normal upper limit)
- •9. Persons with electrolyte anomalies (K test readings outside normal range)
- •10. Persons diagnosed with severe chronic or terminal diseases (such as malignant tumors, tuberculosis, chronic liver disease, epileptic pneumonia, chronic new disease, chronic heart disease, and other rare metabolic disorders)
- •11. Patients with unregulated hypertension (high blood pressure of 160 mgHg in the condenser and patients with high blood pressure exceeding 95 mmHg in the relaxation period)
- •12. Patients with diabetes or insulin-dependent diabetes who are not controlled by blood glucose reduction
- •13 A person who shows low potassium haemorrhosis or who is administering drugs (such as furosemide, thiazide, amphetamine,cisplatin,etc) and a condition that can show low potassium haemorrhosis (such as low magnesium haemorrhosis,Barter syndrome,githelman synthemia,etc) that can cause this.
- •14.A person who is taking blood clotting agents (Greenmono, Advocate, Monoclate-P, Facnye, BenFix, etc.) for cardiovascular disorders or haemostatic disorders
- •15. Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptive disorder.
- •16. Those who do not agree with the contraceptives (dual contraceptives*, intrauterine contraceptives, and murder agents) that are recognized during clinical trials.
- •17. Anyone who has participated in other clinical trials with interventions within the last four weeks
- •18. If compliance with this protocol is deemed difficult, such as treatment, referral, or preparation of questionnaire
- •19. Other clinical research personnel find it inappropriate
研究者
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