Insomnia
Conditions
Interventions
Placebo Group: Anshen Drop Pills Simulant:Anshen Drop Pills Simulant, 1 sachet per dose, once daily, to be taken in the evening
Continue the treatment for 28 consecutive days.
Experimental Group: Anshen Drop Pills:Anshen Drop Pills, 1 sachet per dose, once daily, to be taken in the evening
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria: (1) Aged between 18 and 60 years old (inclusive of 18 and 60 years old) regardless of gender; (2) Meet the diagnostic criteria for insomnia (DSM-V); (3) Diagnosed with the syndrome of heart and liver blood deficiency according to Traditional Chinese Medicine; (4) A total score of >10 on the Pittsburgh Sleep Quality Index (PSQI) during both the screening and baseline periods; (5) A score of =15 on the Insomnia Severity Index (ISI) during both the screening and baseline periods; (6) Based on the investigator's assessment of the participant's self-report within the 4 weeks prior to screening at least 3 nights per week with subjective sleep onset latency (sSOL) =30 minutes subjective wake after sleep onset (sWASO) =30 minutes and subjective total sleep time (sTST) =6.5 hours; and within the 1 week prior to baseline at least 3 nights with subjective sleep onset latency =30 minutes and subjective wake after sleep onset =30 minutes as recorded in the sleep diary; (7) Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Participants with any of the following criteria will be excluded from the trial: (1) Regular use of sleep aids or health supplements; (2) Use of insomnia treatment drugs for =3 days per week on average within 2 weeks before the run-in period or use of insomnia treatment drugs within 2 weeks after the run-in period; (3) History of other sleep-related disorders: narcolepsy circadian rhythm sleep disorder sleepwalking sleep-related breathing disorders obstructive or central sleep apnea syndrome restless legs syndrome etc.; (4) Severe psychiatric disorders or emotional disturbances (such as anxiety depression suicidal tendencies or history of suicide) within the past year or long-term use of central nervous system depressants or stimulants; (5) Hamilton Anxiety Scale score =14 or Hamilton Depression Scale score =17 at screening; (6) Shift work or transmeridian travel across three or more time zones within the past month or anticipated during the trial period; (7) Other causes of insomnia within the past month such as pain fever cough surgery environmental disturbances or stressful life events; (8) Severe cardiovascular pulmonary hepatic renal endocrine or central nervous system diseases; (9) Liver function tests with ALT or AST exceeding 1.5 times the upper limit of normal reference values or Scr exceeding the upper limit of normal reference values; (10) Hypertensive patients with systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after antihypertensive treatment; (11) Drug or alcohol abuse or dependence; (12) Known allergy to the trial drug or its components; (13) Pregnant or lactating women or those unable to use contraception during the trial period; (14) Participation in other drug clinical trials within the past month; (15) Considered unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline to Day 29 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the total score of the Insomnia Severity Index (ISI) from baseline to Day 29 of treatment;The change in the number of subjective awakenings and the number of subjective sleep response days from the 7-day sleep diary prior to baseline to the 7-day sleep diary prior to Day 29 of treatment;The change in the total score of the WHO-5 Well-Being Index from baseline to Day 29 of treatment;The disappearance rate of individual secondary symptoms of Traditional Chinese Medicine (TCM) syndrome on Day 29 of treatment;The change in the total score of the Fatigue Severity Scale (FSS) from baseline to Day 29 of treatment.;Rebound phenomenon: The change in the total score of the Insomnia Severity Index (ISI) from baseline to Day 43 of treatment (Visit 5);The change in the total score of Traditional Chinese Medicine (TCM) syndrome from baseline to Day 29 of treatment;The proportion of sleep extension time to total sleep duration in the 7-day sleep diary prior to Day 29 of treatment;The proportion of participants with a PSQI total score <7 on Day 29 of treatment;The change in the individual scores of the main symptoms of Traditional Chinese Medicine (TCM) syndrome from baseline to Day 29 of treatment;The change in the average values of each assessment item (subjective sleep efficiency, subjective sleep onset latency, subjective total sleep time, subjective wake after sleep onset) from the 7-day sleep diary prior to baseline to the 7-day sleep diary prior to Day 29 of treatment; | — |
Countries
China
Contacts
Public ContactZhi xia Mao
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed