KCT0008391招募中Unknown
A Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Efficacy and Safety of Kami Guibi-tang (KGT) in Elderly Subjects with Insomnia
Kyung Hee University Oriental Medicine Hospital at Gangdong0 个研究点目标入组 34 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Men and women aged 65 or older who complain of insomnia according to the criteria presented by DSM-5
- •2. Insomnia Severity Index - Korean (ISI-K) score of 8 or higher
- •3. SCD-Q score of 7 or more and a KDSQ-C score of less than 6
- •4. Those who have not received any new treatment related to insomnia within the last 2 weeks: Non-drug treatment and drug treatment
- •5. Those who have not received cognitive-related drug treatment within the last 2 weeks
- •6. Those who have been in a stable state for more than four weeks without any change in the medication taken for the underlying disease and is scheduled to be administered stably during the trial period
- •7. Those who have no communication problems
- •8. Those who voluntarily decide to participate and sign the consent form
排除标准
- •1. Diagnosed with dementia according to the NINCDS-ADRDA criteria
- •2. Diagnosed with mild cognitive impairment according to the diagnosis criteria of mild cognitive impairment suggested by Albert et al.
- •3. Brain diseases that cause other neurological symptoms
- •4. Those who have a mental disorder, have behavioral problems that require treatment with psychotropic drugs, or are taking psychotropic drugs
- •5. Substance abuse (drug addiction, alcoholism, etc.)
- •6. Life-threatening physical disabilities requiring immediate treatment
- •7. Uncontrolled hypertension
- •8. Heart or renal disease
- •9. Peripheral edema
- •10. Gastrointestinal symptoms, such as anorexia, stomach discomfort, nausea, abdominal pain, and diarrhea
- •11. Use of medications that could induce hypokalemia or myopathy
- •12. Hypersensitivity to the medication used in the study
- •13. Clinically significant abnormalities in blood chemistry, including levels of serum glutamic pyruvate transaminase (SGPT)/serum glutamic oxaloacetic transaminase (SGOT) being more than twice the normal upper limit, or serum creatinine levels more than 10% above the normal upper limit
- •14. Participation in any other clinical trial within the previous 4 weeks
- •15. Iliteracy
- •16. Considered unsuitable for participation by the investigator
研究者
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