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

Primary Purpose

Primary Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese herbal Medicine
the dummy of a Chinese Medicine prescription
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guang'anmen hospital, China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chinese Medicine group

placebo group

Arm Description

Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change from baseline in sleep onset latency at 4 weeks
change from baseline in wake time after sleep onset at 4 weeks
change from baseline in sleep efficiency at 4 weeks
change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks
change from baseline in Chinese Medicine symptoms and signs at 4 weeks

Full Information

First Posted
May 16, 2012
Last Updated
June 4, 2012
Sponsor
China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01613183
Brief Title
Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (false)

8. Arms, Groups, and Interventions

Arm Title
Chinese Medicine group
Arm Type
Experimental
Arm Description
Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chinese herbal Medicine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
the dummy of a Chinese Medicine prescription
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from baseline in Total Sleep Time (TST) at 4 weeks
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
change from baseline in sleep onset latency at 4 weeks
Time Frame
baseline and 4 weeks
Title
change from baseline in wake time after sleep onset at 4 weeks
Time Frame
baseline and 4 weeks
Title
change from baseline in sleep efficiency at 4 weeks
Time Frame
baseline and 4 weeks
Title
change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks
Time Frame
baseline and 4 weeks
Title
change from baseline in Chinese Medicine symptoms and signs at 4 weeks
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Li, Bachelor
Phone
+8613810991638
Email
leepanns@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyun He, Doctor
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Guang'anmen hospital, China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Runshun Zhang, Doctor
Phone
+86-010-84001440

12. IPD Sharing Statement

Citations:
PubMed Identifier
23448313
Citation
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.
Results Reference
derived

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

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