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

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Primary Insomnia

Treatments: Drug: Chinese herbal Medicine; Other: the dummy of a Chinese Medicine prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT01613183

PJZX-001

81072920 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Chinese Medicine group

Experimental group

Description:

Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians

Treatment:

Drug: Chinese herbal Medicine

placebo group

Placebo Comparator group

Treatment:

Other: the dummy of a Chinese Medicine prescription