Effect of Hwanglyeonhaedok-tang on insomnia: A randomized controlled trial

Daejeon Korean Medicine Hospital of Daejeon University0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1) Adults aged 19 to under 59, of both genders.
•2) Participants meeting the diagnostic criteria for insomnia disorder according to DSM-5.
•3) Participants with a severity score of 15-28 on the Insomnia Severity Index.
•4) Participants with a score of 33-45 on the Bedtime Procrastination Scale.
•5) Participants with a score of 8-26 on the Beck Anxiety Inventory.
•6) Participants scoring 3-5 points on item 13 of the Cold-Heat Pattern Identification questionnaire.
•7) Participants who have voluntarily provided written consent to participate in the clinical trial.

•1) Participants with a history of major psychiatric disorders (such as major depressive disorder, anxiety disorders, obsessive-compulsive disorder, post-traumatic stress disorder, etc.) within the past 2 years.
•2) Participants who have taken the following medications within 4 weeks of the screening visit (antipsychotics, antidepressants, mood stabilizers, benzodiazepines, Z-drugs).
•3) Participants for whom major depressive disorder, panic disorder, generalized anxiety disorder, binge-eating disorder, bulimia nervosa, or alcohol use disorder is suspected based on the Patient Health Questionnaire.
•4) Participants with thyroid disorders or TSH levels = 0.5 µIU/ml or TSH = 7.0 µIU/ml at screening.
•5) Participants with AST or ALT levels = twice the upper limit of normal or Creatinine levels = 2.0 mg/dl at screening.
•6) Participants who have taken investigational products in a clinical trial within 3 months prior to the screening visit.
•7) Pregnant or breastfeeding women or those not employing medically acceptable contraceptive methods during the clinical trial period.
•8) Participants deemed unable to participate in the clinical trial due to other reasons.

发起方

Daejeon Korean Medicine Hospital of Daejeon University