Multicenter randomized controlled clinical trial of Harmonizing the Liver and Spleen in the treatment of Primary Insomnia

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22001145

Enrollment

258

Registered

2014-05-15

Start date

2013-10-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary insomnia Mental and Behavioural Disorders Nonorganic insomnia

Interventions

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. T

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026