KCT0005001招募中未知
Effects of Sihogayonggolmoryeo-tang for insomnia disorder with prehypertension or stage 1 hypertension : a randomized, wait-list controlled, parallel, pilot clinical trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
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) adults aged 19 years or over but under 80 years
- •(2) fulfilment of the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder
- •(3) total score of Insomnia Severity Index (ISI) =15 points
- •(4) patients with prehypertension (systolic blood pressure 120-139 mmHg or diastolic blood pressure 80-89 mmHg) or stage 1 hypertension (systolic blood pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg) defined by seventh report of joint national committee
- •(5) those who have voluntarily signed written informed consent forms approved by the institutional review board (IRB) after sufficient explanation about this study
排除标准
- •(1) those who started taking sleep medication as needed to improve insomnia or who changed the type or dosage of a regularly taken sleep medication within 2 weeks prior to screening
- •(2) those who have taken herbal medicine to improve insomnia within 2 weeks prior to screening or who plan to take it to improve insomnia during the study period
- •(3) those who started Korean medicine treatment (acupuncture, moxibustion, or cupping therapy), dietary supplements, or other non-pharmacological therapies for the purpose of improving insomnia within 2 weeks prior to screening
- •(4) those diagnosed with other sleep disorders besides insomnia such as sleep-related breathing disorder, hypersomnia, circadian rhythm sleep disorder, restless leg syndrome, and periodic limb motor disorder
- •(5) working shifts or changes in day/night work schedule that can impact circadian rhythm
- •(6) those who have been diagnosed with major depressive disorder, anxiety disorder, panic disorder, or other psychiatric disorders or have a Patient Health Questionnaire-9 score = 10
- •(7) those who have pain severe enough to cause sleep disturbance
- •(8) uncontrolled thyroid function (abnormal level of free thyroxine (free T4) and thyroid-stimulating hormone (TSH) < 0.1 µIU/mL or TSH > 5.1 µIU/mL)
- •(9) those who have received antihypertensives, Korean medicine treatment (eg, acupuncture, moxibustion, cupping therapy, herbal medicine), dietary supplement, or other non-pharmacological therapies for the purpose of controlling blood pressure within 4 weeks prior to screening
- •(10) those with a history of aortic constriction, hyperaldosteroneemia, renal artery stenosis, Cushing's disease, chromophiloma, or polycystic kidney disease suspected of secondary hypertension
- •(11) those with a history of asthma, chronic obstructive pulmonary disease, cerebrovascular disease (stroke, transient ischemic attack), cardiovascular disease (myocardial infarction, angina pectoris, heart failure, valve disease), malignant tumors, and active tuberculosis within 6 months prior to screening
- •(12) uncontrolled diabetes mellitus with HbA1c = 9% or fasting blood glucose = 160 mg/dL
- •(13) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial
- •(14) severe liver or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels = 5 times the upper limit of normal or creatinine levels = 2 times the upper limit of normal)
- •(15) those with a history of alcohol abuse or drug abuse
- •(16) those with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •(17) those who are less than 1 month from the end of the intervention in a previous clinical trial
- •(18) those who are thought to be unsuitable for participation in this clinical trial for other reasons
研究者
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