Primary Insomnia
Conditions
Brief summary
The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.
Interventions
The intervention of Chinese Medicine group is not fixed. The clinicians provide the prescription to patient base their own Chinese Medicine theory. Chinese clinicians can adjust the medicinal in prescription based on the condition of patient during the treatment procedure. The prescription of Chinese clinicians' are pure Chinese herb.
OTHERthe dummy of a Chinese Medicine prescription
Patients in placebo group will receive the dummy of the core drug patterns screened in previous retrospective study. The previous core drug patterns include Fried semen Ziziphi Spinosae, Tuckahoe, Preparation of Polygala, Chinese Angelica root, Lotus heart, White peony root, dried tangerine peel, acorus calamus, Coptis chinensis, and Licorice health.
Sponsors
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* aged between 18 and 65 years, * meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) of insomnia, * Spiegel scale score is ≥ 18, * The informed consent must be obtained from patient
Exclusion criteria
* total sleep time ≤ 2 hours, * secondary insomnia, * Self-rating Anxiety Scale (SAS) score ≥ 18, * Beck Depression Inventory (BDI) score ≥ 6, * having hypertension, diabetes, stroke, and coronary heart disease, * have drug abuse history, * pregnancy or preparing to pregnancy, * used immunotherapy or hormone therapy in past 1 years, * participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in Total Sleep Time (TST) at 4 weeks | baseline and 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline in sleep onset latency at 4 weeks | baseline and 4 weeks |
| change from baseline in wake time after sleep onset at 4 weeks | baseline and 4 weeks |
| change from baseline in sleep efficiency at 4 weeks | baseline and 4 weeks |
| change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks | baseline and 4 weeks |
| change from baseline in Chinese Medicine symptoms and signs at 4 weeks | baseline and 4 weeks |
Countries
China
Contacts
Primary ContactPeng Li, Bachelor
Outcome results
None listed