RecruitingPhase 2

Chinese Medicine in Treating Insomnia

Hong Kong76 participantsStarted 2025-09-25

Plain-language summary

This is a randomized, double-blinded, placebo-controlled clinical trial. Eligible participants will randomized into either treatment group (CM granules) or placebo group (placebo granules) for 6 weeks, followed by a post-treatment visit at week 9. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) at week 6.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Week 6

Trial details

NCT IDNCT06511011

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Zhixiu Lin

39436347 linzx@cuhk.edu.hk

View on ClinicalTrials.gov More Insomnia Chronic trials