KCT0006803已完成未知
Pharmacopuncture Effects on Insomnia Disorder : Multi-site, Pragmatic randomized controlled, Acupuncture control, Strategic Comparative Clinical Study
Pusan National University Korean Medicine Hospital0 个研究点目标入组 138 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 138
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) Adult men and women aged 19 to 80 years old.
- •2) Those with 15 or more Insomniia Severity Index (ISI) scores.
- •3) Those who meet the criteria for diagnosing insomnia in DSM-5
- •4) A person who agreed to participate and signed the subject's consent form after hearing a clear explanation of the purpose and characteristics of this clinical trial.
排除标准
- •1) A person who has changed the type or dose of sleeping pills regularly taken to improve insomnia within the last 4 weeks.
- •2) A person who has received oriental medicine treatment (puncture, moxibustion, cupping, and herbal medicine) for the purpose of improving insomnia within the last 4 weeks.
- •3) A person who has started health supplements or other non-drug therapy (cognitive behavior therapy, meditation, etc.) for the purpose of improving insomnia within the last 4 weeks or is scheduled to start anew during clinical trials.
- •4) Those who have participated in other clinical trials with intervention within the last 4 weeks.
- •5) A person who changes shift work and working hours during the day and night that can clearly affect the living cycle.
- •6) A person with a clear pain enough to interfere with sleep or a disease that can cause sleep.
- •7) Those who have been diagnosed with unstable (controllable) schizophrenia, bipolar disorder, and other mental disorders in the last 6 months and are currently being treated, or those with an anxiety or depression score of 11 or higher on the Hospital Anxiety and Depression Scale (HADS)
- •8) A person diagnosed with a serious chronic disease or terminal disease (malignant tumor, tuberculosis, chronic liver disease, interstitial pneumonia, chronic renal disease, chronic heart disease, and other rare metabolic diseases, etc.) and is being treated.
- •9) Those with abnormal hormone levels on thyroid function tests (free T4 is abnormal and TSH <0.1 uIU/ml or TSH> 5.1 uIU/ml factor)
- •10) Those with clinically significant abnormalities in Blood chemistry (SGPT, SGOT: More than twice the upper limit of one or more of the two, serum creatinine: 1.5 times or more of the normal upper limit)
- •11) Those with electrolyte abnormalities (normal range of 5% or more and less).
- •12)High blood pressure patients who are not controlled by hypotension drugs (high blood pressure patients with systolic blood pressure exceeding 160mmHg and diastolic blood pressure exceeding 90mmHg)
- •13) Diabetes or insulin-dependent diabetes patients who are not controlled by blood glucose lowering agents (those with HbA1c greater than 7%)
- •14) Those who are taking blood coagulants (Greenmono, Advate, Monoclate-P, Facnyne, BenFix, etc.) due to cardiovascular abnormalities or hemostatic disorders.
- •15) A person who disagrees with the contraception method (double contraception method*, intrauterine contraceptive devices, and lethal drugs) recognized during the clinical trial period, with the possibility of pregnancy, lactating, and pregnant women.
- •16) In a case where it is deemed difficult to comply with the treatment, visit the hospital, or fill out a questionnaire under this protocol, etc.
- •17) In the case where the person in charge of other clinical research determines that it is inappropriate.
研究者
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