KCT0003235已完成未知
Electro-acupuncture for treating the treatment-resistant insomnia : randomized controlled, assessor-blinded, pilot clinical trial
Pusan National University Korean Medicine Hospital0 个研究点目标入组 50 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
- 50
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. Patients aged 19 years - 80 years
- •2. Patinets who continous taking medication for improving insomnia symptoms over the last 3 months, and not changed their regular medication type or doseage to improve insomnia within the last 2 weeks
- •3. Total score in the Insomnia Severity Index (ISI)=15 points
- •4. fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) diagnostic criteria for insomnia disorder
- •5. Willingness to participate in the trial and having provided written consent
排除标准
- •1. Having undergone Korean medical treatment (eg, acupuncture, moxibustion, cupping, herbal medicine) within last 2 weeks for improving insomnia
- •2. Initiation the dietary supplement regimen or non-pharmacological therapies (eg, cognitive behavioural therapy, meditation, etc) to alleviate insomnia within the last 2 weeks or plans for initiation during the trial.
- •3. 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
- •4. The patients with substance abuse/dependence within last 6 months
- •5. Having experienced suicide/murder/self-injury attempt
- •6. Working shifts or changes in day/night work schedule that could impact circadian rhythm
- •7. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia
- •8. Taking haemostatic agents (eg, Greenmono, Advate, Monoclate-P, Facnyne, BeneFix) because of cardiovascular or haemostatic disorders
- •9. 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)
- •10. 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, WBC count < 1,500 ? or =10,000 ?, Absolute Neutrophil Count(ANC)< 1,000, platelets count < 75,000/µL, positive in urine HCG, or other abnormal findings that could impact the trial by investigator’s decision)
- •11. Diagnosed serious chronic disease (e.g. malignant tumor, active pulmonary tuberculosis, chronic liver disease or chronic kidney disease ect.)
- •12. History of hypersensitivity reactions to acupuncture or inability to cooperate with acupuncture therapy
- •13. The presence of implants that could interfere with EA or a history of hypersensitivity reactions to electrostimulation
- •14. Pregnancy, lactation or planning to become pregnant
- •15. Having participated in other clinical trials within 4 weeks of the beginning of the trial
- •16. Difficulty complying with the study protocol(treatment, visiting, filling in questionnaries)
- •17. Subjects who are not appropriate by investigator’s decision
研究者
相似试验
尚未招募
1 期
Efficacy of electroacupuncture for the treatment of Postherpetic Neuralgia: study protocol for a multicenter randomized controlled trialzoster-associated painITMCTR2100005431Hangzhou Third People's Hospital
尚未招募
1 期
Efficacy of electroacupuncture for the treatment of subacute Zoster-associated Pain: study protocol for a multicenter randomized controlled trialzoster-associated painITMCTR2100005410Hangzhou Third People's Hospital
招募中
1 期
Application of electroacupuncture combined with erector spinae plane block in anesthesia of non tracheal intubation thoracoscopic surgeryThoracoscopic lobectomyITMCTR2000003773Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Medicine
尚未招募
1 期
Electroacupuncture for pain improvement in patients with postherpetic neuralgia : a single arm pilot studyPostherpetic neuralgiaITMCTR2100005386Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
尚未招募
1 期
The scheme and application of electroacupuncture to promote early gastrointestinal function rehabilitation after laparoscopic gastric cancer operatiogastricITMCTR2100005260Affiliated Hospital of Nanjing University of Traditional Chinese Medicine