Chinese medicine blend for chronic insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, double-blind, placebo-controlled study. Participants with chronic insomnia are assigned to receive either the modified Chinese herbal formula or placebo for 6 weeks, with a follow-up visit at week 9. The main outcome is the change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 6. Eligible participants are adults aged 18–65 meeting DSM-5 insomnia criteria and an insomnia severity index of at least 8, with a Yin deficiency-internal heat pattern per traditional Chinese medicine. Safety and efficacy will be monitored through standardized questionnaires and adverse event reporting. The study is led by the Chinese University of Hong Kong at the Hong Kong Institute of Integrative Medicine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age from 18 to 65 years;
* Eligible for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, criteria for insomnia disorder. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 nights per week for at least 6 months;
* Insomnia Severity Index (ISI) total score of at least 8 indicating insomnia at the clinical level;
* Diagnosed to be Yin deficiency-induced internal heat pattern according to traditional Chinese Medicine (TCM) theory;
* Able to complete questionnaires and take medications as scheduled; and
* Voluntary written consent.

Exclusion Criteria:

* Known nervous system disease (eg, stroke, Parkinson's Disease);
* Known mental disorders (eg, depression or anxiety) or HADS score 11 or above in any either item;
* Known sleeping related diseases (eg. sleep apnea, nocturnal myoclonus, restless legs, severe nocturnal enuresis or narcolepsy) that may affect the sleeping quality;
* Known pharmacologically induced insomnia;
* With symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturition, and cough;
* Know treatment to comorbid sleep disorders, such as sleep apnea or narcolepsy;
* Work on shift or on night shift;
* Concomitant pharmacological treatment or herbal medicines for insomnia within the past month;
* Known severe medical conditions, such as cardiovascular, liver, kidney or hematopoietic system disease, diabetes mellitus, cancers, cerebrovascular diseases;
* Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
* Known alcohol and / or drug abuse;
* Known allergic history to any Chinese herbal medicines;
* Diagnosed to be deficiency of spleen according to TCM theory;
* Any contraindications for taking Chinese medicines in the opinion of the investigators;
* Know pregnant or lactating; and
* Involved in other interventional clinical studies at the same time.

Where it's running

• Hong Kong Institute of Integrative Medicine
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Zhixiu Lin — Chinese University of Hong Kong
• Study coordinator: Zhixiu Lin
• Email: linzx@cuhk.edu.hk
• Phone: 39436347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.