Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia

Study Overview
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Brief Summary
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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.

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: Chinese herbal Medicine
* Other: the dummy of a Chinese Medicine prescription


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Medicine group<br>Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians | Drug: Chinese herbal Medicine<br>* 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.<br>|
| Placebo Comparator: placebo group<br> | Other: the dummy of a Chinese Medicine prescription<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Total Sleep Time (TST) at 4 weeks |  | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |