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

Not Applicable

• Conditions: Primary Insomnia
• Interventions: Drug: Chinese herbal Medicine; Other: the dummy of a Chinese Medicine prescription

• Registration Number: NCT01613183
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-16
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-04
• Last Update Submitted: 2012-06-04
• Study First Posted: 2012-06-07
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese Medicine group	Chinese herbal Medicine	Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians
placebo group	the dummy of a Chinese Medicine prescription	-

Primary Outcome Measures

Name	Time	Method
change from baseline in Total Sleep Time (TST) at 4 weeks	baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guang'anmen hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China