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
Qualifiers
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
Treatments tested in this trial
- Modified Suan ZaoRen Tang-TianWang BuXin Dan
- Placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov