Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
NCT ID: NCT01613183
Last Updated: 2012-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2 participants
INTERVENTIONAL
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Chinese Medicine group
Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians
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.
placebo group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Liyun He
Director, Principal Investigator
Principal Investigators
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Liyun He, Doctor
Role: STUDY_CHAIR
China Academy of Chinese Medical Sciences
Locations
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Guang'anmen hospital, China Academy of Chinese Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Runshun Zhang, Doctor
Role: primary
References
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Xiong ZY, Lu Y, He LY, Zhang RS, Zhou XZ, Li P, Liu YJ, Zhu JG, Yan SY, Liu BY. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial. Chin J Integr Med. 2024 Oct;30(10):867-876. doi: 10.1007/s11655-024-3661-4. Epub 2024 May 16.
Yan S, Zhang R, Zhou X, Li P, He L, Liu B. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial. Trials. 2013 Feb 28;14:61. doi: 10.1186/1745-6215-14-61.
Other Identifiers
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81072920
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PJZX-001
Identifier Type: -
Identifier Source: org_study_id
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