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

Primary Insomnia Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01613183
• Other study ID #: PJZX-001
• Secondary ID: 81072920
• Status: Unknown status
• Phase: N/A
• First received: May 16, 2012
• Last updated: June 4, 2012
• Start date: May 2012

Study information

• Verified date: June 2012
• Source: China Academy of Chinese Medical Sciences
• Contact: Peng Li, Bachelor
• Phone: +8613810991638
• Email: leepanns[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 2
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Chinese herbal Medicine
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.

Other:
• the 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.

Locations

Country	Name	City	State
China	Guang'anmen hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in Total Sleep Time (TST) at 4 weeks		baseline and 4 weeks
Secondary	change from baseline in sleep onset latency at 4 weeks		baseline and 4 weeks
Secondary	change from baseline in wake time after sleep onset at 4 weeks		baseline and 4 weeks
Secondary	change from baseline in sleep efficiency at 4 weeks		baseline and 4 weeks
Secondary	change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks		baseline and 4 weeks
Secondary	change from baseline in Chinese Medicine symptoms and signs at 4 weeks		baseline and 4 weeks