Condition category
Mental and Behavioural Disorders
Date applied
26/04/2014
Date assigned
15/05/2014
Last edited
04/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many people suffer from trouble with sleeping because of social, hormonal and behavioral changes. Hypnotics are the most common treatment for insomnia. More or less hypnotics may change the normal structure of sleep, which causes worse daytime impairment. Chinese herbs have fewer side effects than hypnotics. We will evaluate the effectiveness of Chinese herbs to improve the treatment of patients with insomnia.

Who can participate?
Any patient aged 18 to 65 years who has suspected insomnia within the recruited sites will be included in the study.

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive Chinese herb granules and the group will get placebo (dummy) granules. All groups will be measured at the start of the study, after 4 weeks of treatment, after 8 weeks of treatment, just before both groups get one final treatment booster session, and again after 1 month to see if the treatment is effective in the long term.

What are the possible benefits and risks of participating?
Possible benefits for participants are deeper and longer sleep, and improvements of daily functioning that may have been affected by long-term sleep problems, like social functioning. We do not foresee any additional risks to patients in either group of the study.

Where is the study run from?
The study is set up and run by Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing University of Chinese Medicine Dongfang Hospital and Beijing University of Chinese Medicine Dongzhimen Hospital.

When is the study starting and how long is it expected to run for?
March 2014 to September 2016

Who is funding the study?
Beijing Municipal Science & Technology Commission (China)

Who is the main contact?
Prof Qing-Quan Liu, Chief Investigator
Dr Xue-Qi Zhu ,Trial Coordinator (zhuxueqi615@hotmail.com)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Qing-Quan Liu

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Z13110200680000

Study information

Scientific title

A multi-center double-blind, randomized, placebo-controlled study to test the clinical efficacy and safety of harmonizing the liver and spleen in the treatment of primary insomnia

Acronym

HLSPI

Study hypothesis

To evaluate the efficacy of Chaihuguizhiganjiang-suanzaoren decoction granules in patients with primary insomnia.

Ethics approval

Medical Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine; 03/07/2014

Study design

Multi-center double-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary insomnia

Intervention

The subjects were treated once daily for 8 weeks with herb or placebo granules.

The experimental intervention is chaihuguizhiganjiang-suanzaoren decoction granules, based on 13 TCM herbs/products.

The control intervention is placebo granules, concluded 5% herbal decoction and 95% saccharose, and is similar to the experimental granules in the aspects of color, taste, smell and package.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Sleepiness measured using the Pittsburgh sleep quality index (PSQI). Assessments will be measured at baseline, post-treatment evaluation and the 12-week follow-up evaluations.

Secondary outcome measures

1. Changes in the Insomnia Severity Index (ISI). Assessments will be conducted at baseline, post-treatment evaluation and the 12-week follow-up evaluations.
2. Sleep efficiency (SE) from sleep diary will be conducted every day until 12-week follow-up.
3. Changes in the 36-item Short Form Health Survey (SF-36) scores. Assessments will be conducted at baseline, post-treatment evaluation and the 12-week follow-up evaluations.
4. A safety evaluation of the intervention.

Overall trial start date

01/10/2013

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women aged 18 to 65 years
2. Primary insomnia diagnosed from The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
3. Syndromes of spleen deficient and liver heat according to the traditional Chinese medicine clinical trial guiding principles for the treatment of insomnia.
4. Sleep difficulties lasting 1 month or longer, complaint of poor sleep (difficulty initiating and/or maintaining sleep, early morning awakening, or non-restorative sleep)
5. Not to receive another treatment during the clinical trial period
6. Written and informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

258

Participant exclusion criteria

1. Diagnosis of secondary insomnia
2. The score of Self-Rating Anxiety Scale (SAS) greater than 60 or the score of Self-Rating Depression Scale (SDS) greater than 63
3. Possible significant mental (e.g. depression) or physical health problems (e.g. cardiovascular disease)
4. A primary diagnosis of alcohol or substance dependency
5. A learning disability
6. Women in pregnancy and lactation or without contraception

Recruitment start date

01/10/2013

Recruitment end date

30/09/2016

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China

Sponsor information

Organisation

Beijing Municipal Science & Technology Commission (China)

Sponsor details

Building 2
the 7th hospital
Sijiqing Street
Haidian District
Beijing
100195
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Science & Technology Commission (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26839010

Publication citations

Additional files

Editorial Notes

03/02/2016: Publication reference added.