Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
2 other identifiers
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedJune 7, 2012
June 1, 2012
May 16, 2012
June 4, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline in Total Sleep Time (TST) at 4 weeks
baseline and 4 weeks
Secondary Outcomes (5)
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
Study Arms (2)
Chinese Medicine group
EXPERIMENTALChinese Medicine prescription of one of three prestigious Chinese medicine clinicians
placebo group
PLACEBO COMPARATORInterventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guang'anmen hospital, China Academy of Chinese Medical Sciences
Beijing, 100700, China
Related Publications (2)
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.
PMID: 38753273DERIVEDYan 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.
PMID: 23448313DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liyun He, Doctor
China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Principal Investigator
Study Record Dates
First Submitted
May 16, 2012
First Posted
June 7, 2012
Study Start
May 1, 2012
Last Updated
June 7, 2012
Record last verified: 2012-06