Insomnia ChronicPhase 2NCT06511011
Chinese Medicine in Treating Insomnia
A Phase 2 study testing Modified Suan ZaoRen Tang-TianWang BuXin Dan in people with Insomnia Chronic, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Modified Suan ZaoRen Tang-TianWang BuXin Dan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Sep 2025to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Institute of Integrative Medicine
Shatin
Zhixiu Lin, 852-28733252, linzx@cuhk.edu.hk
About this study
Official title: Efficacy and Safety of Modified Suan ZaoRen Tang-TianWang BuXin Dan in the Treatment of Chronic Insomnia: A Randomized, Double-blinded, Placebo-controlled Trial
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.
Read the detailed description
Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms.
Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.
- Conditions
- Insomnia Chronic
- Being tested
- Modified Suan ZaoRen Tang-TianWang BuXin Dan, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Suan ZaoRen Tang-TianWang BuXin DanDrug
Also called mSZT-TBD
Chinese medicine granules for 6 weeks
PlaceboDrug
Also called Placebo granules
Placebo granules for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| mSZT-TBD granules | Experimental | Modified Suan ZaoRen Tang-TianWang BuXin Dan granules Receives: Drug: Modified Suan ZaoRen Tang-TianWang BuXin Dan |
| Placebo granules | Placebo comparator | Placebo granules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Pittsburgh Sleep Quality Index (PSQI)
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
Measured: Week 6
Secondary outcomes (9)
The change in Pittsburgh Sleep Quality Index (PSQI)
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
Measured: Week 3
The change in Pittsburgh Sleep Quality Index (PSQI)
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
Measured: Week 9
Sleep parameter data
Wrist actigraphy, which is a small size monitor, is an alternative to objectively measure the sleep patterns of subjects, the measuring parameters include sleep onset latency (SOL), wake time after sleep onset (WASO), total sleep time duration (TST), total time in bed (TIB), and sleep efficiency (SE). The actigraph will be recorded using Philips Actiwatch 2.
Measured: From baseline to week 9.
The change in Insomnia Severity Index (ISI)
ISI is a self-reported questionnaire to assess both daytime and nighttime components of insomnia. It consists of seven items to evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28
Measured: Week 3
The change in Insomnia Severity Index (ISI)
ISI is a self-reported questionnaire to assess both daytime and nighttime components of insomnia. It consists of seven items to evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28
Measured: Week 6
The change in Insomnia Severity Index (ISI)
ISI is a self-reported questionnaire to assess both daytime and nighttime components of insomnia. It consists of seven items to evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28
Measured: Week 9
The change in Hospital Anxiety and Depression Scale (HADS)
HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.
Measured: Week 3
The change in Hospital Anxiety and Depression Scale (HADS)
HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.
Measured: Week 6
The change in Hospital Anxiety and Depression Scale (HADS)
HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start25 Sep 2025
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511011
- Sponsor's protocol ID
- Insomnia study
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Modified Suan ZaoRen Tang-TianWang BuXin Dan in the Treatment of Chronic Insomnia: A Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06511011
- Acronym / sponsor ID
- Insomnia study
- Conditions
- Insomnia Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms.
Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mSZT-TBD granules | Experimental | Drug: Modified Suan ZaoRen Tang-TianWang BuXin DanModified Suan ZaoRen Tang-TianWang BuXin Dan granules |
| Placebo granules | Placebo comparator | Drug: PlaceboPlacebo granules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Suan ZaoRen Tang-TianWang BuXin DanAlso: mSZT-TBDChinese medicine granules for 6 weeks | Drug | mSZT-TBD granules |
| PlaceboAlso: Placebo granulesPlacebo granules for 6 weeks | Drug | Placebo granules |
Primary outcome
The change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 6
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
9 secondary outcomes
The change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 3
The change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 9
Sleep parameter data
Time frame: From baseline to week 9.
The change in Insomnia Severity Index (ISI)
Time frame: Week 3
The change in Insomnia Severity Index (ISI)
Time frame: Week 6
The change in Insomnia Severity Index (ISI)
Time frame: Week 9
The change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 3
The change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 6
The change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhixiu Lin principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modified Suan ZaoRen Tang-TianWang BuXin Dan in people with Insomnia Chronic, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhixiu Lin (39436347, linzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Pittsburgh Sleep Quality Index (PSQI) (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.