Chinese Medicine in Treating Insomnia
ConditionInsomnia Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese University of Hong Kong
About this trial
This is a randomized, double-blinded, placebo-controlled clinical trial. Eligible participants will randomized into either treatment group (CM granules) or placebo group (placebo granules) for 6 weeks, followed by a post-treatment visit at week 9. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) at week 6.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 65 years;
Eligible for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, criteria for insomnia disorder. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 nights per week for at least 6 months;
Insomnia Severity Index (ISI) total score of at least 8 indicating insomnia at the clinical level;
Diagnosed to be Yin deficiency-induced internal heat pattern according to traditional Chinese Medicine (TCM) theory;
Disqualifiers
Known nervous system disease (eg, stroke, Parkinson's Disease);
Known mental disorders (eg, depression or anxiety) or HADS score 11 or above in any either item;
Known sleeping related diseases (eg. sleep apnea, nocturnal myoclonus, restless legs, severe nocturnal enuresis or narcolepsy) that may affect the sleeping quality;
Known pharmacologically induced insomnia;
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Suan ZaoRen Tang-TianWang BuXin Dan
DrugChinese medicine granules for 6 weeks
Placebo
DrugPlacebo granules for 6 weeks
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: mSZT-TBD granulesExperimental treatment 1 intervention
Group B: Placebo granulesPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in Pittsburgh Sleep Quality Index (PSQI)
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
Time frame
Week 6Secondary outcomes
1
The change in Pittsburgh Sleep Quality Index (PSQI)
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
Time frame
Week 32
The change in Pittsburgh Sleep Quality Index (PSQI)
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
Time frame
Week 93
Sleep parameter data
Wrist actigraphy, which is a small size monitor, is an alternative to objectively measure the sleep patterns of subjects, the measuring parameters include sleep onset latency (SOL), wake time after sleep onset (WASO), total sleep time duration (TST), total time in bed (TIB), and sleep efficiency (SE). The actigraph will be recorded using Philips Actiwatch 2.
Time frame
From baseline to week 9.4
The change in Insomnia Severity Index (ISI)
ISI is a self-reported questionnaire to assess both daytime and nighttime components of insomnia. It consists of seven items to evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28
Time frame
Week 3Sponsors and contacts
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Source ClinicalTrials.gov