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.
Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms. Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
Chinese medicine granules for 6 weeks
Placebo granules for 6 weeks
Hong Kong Institute of Integrative Medicine
Shatin, Hong Kong
RECRUITINGThe 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 6
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 3
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 9
Sleep parameter data
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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.
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 3
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 6
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 9
The change in Hospital Anxiety and Depression Scale (HADS)
HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.
Time frame: Week 3
The change in Hospital Anxiety and Depression Scale (HADS)
HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.
Time frame: Week 6
The change in Hospital Anxiety and Depression Scale (HADS)
HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.
Time frame: Week 9