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

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total score on the Insomnia Severity Index (ISI) from baseline to post-treatment (4 weeks)

Secondary Outcome Measures

Name	Time	Method
Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), and Bedtime Procrastination Duration (BPD) as measured through sleep diaries;Pittsburgh Sleep Quality Index (PSQI);Bedtime Procrastination Scale (BPS);Patients’ Global Impression of Change (PGIC);(Exploratory outcome) Perceived Stress Scale (PSS);(Exploratory outcome) Beck Anxiety Inventory (BAI);(Exploratory outcome) Heat score on the Cold-Heat Pattern Identification questionnaire;(Exploratory outcome) Achievement of smartphone usage goals (restriction of usage 30 minutes before bedtime, daily usage duration);(Exploratory outcome) Smartphone usage time (min/day);(Exploratory outcome) Smartphone Addiction Scale short version (SAS-SV);(Exploratory outcome) Heart Rate Variability