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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
History of Changes
  Purpose

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.


Condition Intervention
Primary Insomnia
 Drug: Chinese herbal Medicine
Other: the dummy of a Chinese Medicine prescription

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • change from baseline in Total Sleep Time (TST) at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2
Study Start Date: May 2012
Arms Assigned Interventions
Experimental: Chinese Medicine group
Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians
 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.
Placebo Comparator: placebo group 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613183

Contacts
Contact: Peng Li, Bachelor +8613810991638 leepanns@gmail.com

Locations
China
Guang'anmen hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, China, 100700
Contact: Runshun Zhang, Doctor     +86-010-84001440        
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Study Chair: Liyun He, Doctor China Academy of Chinese Medical Sciences
  More Information

No publications provided by China Academy of Chinese Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Liyun He, Director, Principal Investigator, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01613183     History of Changes
Other Study ID Numbers: PJZX-001, 81072920
Study First Received: May 16, 2012
Last Updated: June 4, 2012
Health Authority: China: National Natural Science Foundation

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013