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

June 4, 2012 updated by: Liyun He, China Academy of Chinese Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100700
        • Recruiting
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
        • Contact:
          • Runshun Zhang, Doctor
          • Phone Number: +86-010-84001440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in Total Sleep Time (TST) at 4 weeks
Time Frame: baseline and 4 weeks
baseline and 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Liyun He, Doctor, China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJZX-001
  • 81072920 (Other Grant/Funding Number: National Natural Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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