KCT0009329Not yet recruitingUnknown
Effect of Hwanglyeonhaedok-tang on insomnia: A randomized controlled trial
Daejeon Korean Medicine Hospital of Daejeon University0 sites60 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19(Year) to 59(Year) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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