KCT0005127已完成未知
Hominis Placenta Pharmacopuncture for treating insomnia disorder: randomized placebo controlled, assessor single-blinded, pilot clinical trial study
Pusan National University Korean Medicine Hospital0 个研究点目标入组 51 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
- 51
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 80?(Year)（—）
- 性别
- All
入选标准
- •1. Male and female patients aged 19 years - 80 years
- •2. Total score in the Insomnia Severity Index (ISI)=15 points
- •3. Fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) diagnostic criteria for insomnia disorder
- •4. Willingness to participate in the trial and having provided written consent
排除标准
- •1. Having taken medicines improving insomnia within last 4 weeks for improving insomnia
- •2. Having undergone Korean medical treatment (eg, acupuncture, moxibustion, cupping, herbal medicine) within last 4 weeks for improving insomnia
- •3. Initiation the dietary supplement regimen or non-pharmacological therapies (eg, cognitive behavioural therapy, meditation, etc) for improving insomnia within the last 4 weeks or plans for initiation during the trial.
- •4. The patients with unstable(not controlled) schizophrenia, mania, bipolar disorder within last 6 months, or a subscale of either anxiety or depression in Hamilton Anxiety and Depression Scale score =11 points
- •5. Working shifts or changes in day/night work schedule that could impact circadian rhythm
- •6. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia
- •7. Abnormal findings in thyroid function test (abnormal level of free thyroxine (free T4) and thyroid-stimulating hormone (TSH) <0.1 µIU/mL or TSH >5.1 µIU/mL)
- •8. Inadequate findings in laboratory test(total bilirubin> 2 times compared to the normal upper limit in research institute, ALT(Alanine transaminase) or AST(Aspartate transaminase) > 2.5 times compared to the normal upper limit in research institute, Creatinine > 2.5 times compared to the normal upper limit in research institute, positive in urine HCG, or other abnormal findings that could impact the trial by investigator’s decision)
- •9. Participants with electrolyte abnormality (K test values outside the normal range)
- •10. Diagnosed serious chronic disease (e.g. malignant tumor, active pulmonary tuberculosis, chronic liver disease or chronic kidney disease, other Rare Metabolic Diseases, Genetic Diseases, and Hormone Disorders ect.)
- •11. Participants with uncontrolled hypertension (hypertension with a systolic blood pressure exceeding 160 mgHg and diastolic blood pressure exceeding 95 mmHg)
- •12. Participants with a diabetes or insulin-dependent diabetes who is not controlled by hypoglicemic agents (HbA1c > 6.5 and above)hypoglycemic agent
- •13. Taking haemostatic agents (eg, Greenmono, Advate, Monoclate-P, Facnyne, BeneFix) because of cardiovascular or haemostatic disorders
- •14. Participants who is hypersensitive to PLC and other drugs.
- •15. Participants suspected of having a organic disorder.
- •16. Participants with psychogenic conditions
- •17. Pregnancy, lactation or planning to become pregnant
- •18. Having participated in other clinical trials within 12 weeks of the beginning of the trial
- •19. Difficulty complying with the study protocol(treatment, visiting, filling in questionnaries)
- •20. Subjects who are not appropriate by investigator’s decision
研究者
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