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

This study is currently recruiting participants.
Verified June 2012 by China Academy of Chinese Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Liyun He, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01613183
First received: May 16, 2012
Last updated: June 4, 2012
Last verified: June 2012

May 16, 2012
June 4, 2012
May 2012
Not Provided
change from baseline in Total Sleep Time (TST) at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01613183 on ClinicalTrials.gov Archive Site
  • change from baseline in sleep onset latency at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in wake time after sleep onset at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in sleep efficiency at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in Chinese Medicine symptoms and signs at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Primary Insomnia
  • 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.
    Other Name: the dummy of a Chinese Medicine prescription
  • Experimental: Chinese Medicine group
    Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians
    Intervention: Drug: Chinese herbal Medicine
  • Placebo Comparator: placebo group
    Intervention: Other: the dummy of a Chinese Medicine prescription
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2
Not Provided
Not Provided

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.
Both
18 Years to 65 Years
No
Contact: Peng Li, Bachelor +8613810991638 leepanns@gmail.com
China
 
NCT01613183
PJZX-001, 81072920
No
Liyun He, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
Not Provided
Study Chair: Liyun He, Doctor China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP