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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences

Criteria

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.