Insomnia DisorderPhase 4NCT07306494
Compound Ciwujia Granules in the Treatment of Insomnia
A Phase 4 study testing Compound Ciwujia Granules group, Estazolam and Compound Ciwujia Granules and estazolam in people with Insomnia Disorder, run by Hui Zhu.
Trial summary
The goal of this multicenter, double-blind, double-dummy, randomized controlled trial was to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Compound Ciwujia Granules group, Estazolam and Compound Ciwujia Granules and estazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jun 2028
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]);
- self-reported history of disturbed sleep (i.e, all the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, and self-reported total sleep time of ≤6·5 h) on at least three nights per week for at least 3 months before screening;(3) diagnosis of "deficiency of the heart and the spleen pattern" or "Qi deficiency of the heart and gallbladder pattern" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023;
- baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.
Who cannot join
- self-reported allergy symptoms to any of the ingredients;
- serious physical sickness;
- a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy;
- baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;
- pregnant women;
- history of drugs or alcohol abuse/dependence;
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- presence of other sleep disorders including sleep apnoea, restless legs syndrome;
- night, morning or rotating shift work;
- participation in concurrent clinical trials.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Compound Ciwujia Granules in the Treatment of Insomnia: a Multi-center, Double-blind, Double-dummy, Randomized Controlled Trial
The goal of this multicenter, double-blind, double-dummy, randomized controlled trial was to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia. A total of 1200 participants with chronic insomnia were randomly assigned to receive one of the three treatment for 4 consecutive weeks: Compound Ciwujia Granules + placebo of estazolam, estazolam + placebo of estazolam + placebo of Compound Ciwujia Granules, or Compound Ciwujia Granules + estazolam + placebo of estazolam. Outcomes were assessed at 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The main questions it aims to answer are:
- Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.
- Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?
Read the detailed description
The investigators aimed to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia in a multicenter, double-blind, double-dummy, randomized controlled clinical trial. Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]) or self-reported history of disturbed sleep, diagnosis of "deficiency of the heart and the spleen pattern" or "Qi deficiency of the heart and gallbladder pattern" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023, baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8. The exclusion criteria were (1) self-reported allergy symptoms to any of the ingredients; (2) serious physical sickness; (3) a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy; (4) baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;(5) pregnant women; (6) history of drugs or alcohol abuse/dependence; (7) presence of other sleep disorders including sleep apnoea, restless legs syndrome; (8) night, morning or rotating shift work; (9) participation in concurrent clinical trials. The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) score after 4 weeks' treatment. The secondary outcomes were changes in Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine, as well as the occurrence of adverse events after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.
The main questions it aims to answer are:
- Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics usage, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.
- Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?
- Conditions
- Insomnia Disorder
- Being tested
- Compound Ciwujia Granules group, Estazolam, Compound Ciwujia Granules and estazolam
- Keywords
- Compound Ciwujia Granules, multicenter, randomized controlled trial, insomnia
- 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.
Compound Ciwujia Granules groupDrug
Compound Ciwujia Granules for 4 consecutive weeks combined with placebo of estazolam for 4 consecutive weeks
EstazolamDrug
estazolam for 2 consecutive weeks + placebo of estazolam for 2 consecutive weeks combined with placebo of Compound Ciwujia Granules for 4 consecutive weeks
Compound Ciwujia Granules and estazolamDrug
Compound Ciwujia Granules for 4 consecutive weeks combined with estazolam for 2 consecutive weeks+ placebo of estazolam for 2 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Compound Ciwujia Granules | Experimental | Not described Receives: Drug: Compound Ciwujia Granules group |
| Treatment of estazolam | Active comparator | Not described Receives: Drug: Estazolam |
| Combined treatment of Compound Ciwujia Granules and estazolam | Other | Not described Receives: Drug: Compound Ciwujia Granules and estazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI) score
PSQI score, 0-21, and higher scores mean a poorer sleep quality.
Measured: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Secondary outcomes (5)
Insomnia Severity Index (ISI) score
ISI score, 0-28, and higher scores mean a worse sleep problem
Measured: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Hamilton Depression Scale (HAMD-17) score
HAMD-17 score, 0-55, and higher scores mean more severe depression.
Measured: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks
Hamilton Anxiety Scale (HAMA-14) score
HAMA-14 score, 0-56, and higher scores mean more severe anxiety
Measured: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Flinders Fatigue Scale (FFS) score
FFS score, 0-31, and higher scores mean more severe fatigue
Measured: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks
Occurrence of adverse events
Measured: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Zhu, Hubei Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306494
- Sponsor's protocol ID
- HBZY2024-C61-03
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compound Ciwujia Granules in the Treatment of Insomnia: a Multi-center, Double-blind, Double-dummy, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07306494
- Acronym / sponsor ID
- HBZY2024-C61-03
- Conditions
- Insomnia Disorder
- Keywords
- Compound Ciwujia Granules, multicenter, randomized controlled trial, insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Hui ZhuUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Dec 2025 (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.
The goal of this multicenter, double-blind, double-dummy, randomized controlled trial was to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia. A total of 1200 participants with chronic insomnia were randomly assigned to receive one of the three treatment for 4 consecutive weeks: Compound Ciwujia Granules + placebo of estazolam, estazolam + placebo of estazolam + placebo of Compound Ciwujia Granules, or Compound Ciwujia Granules + estazolam + placebo of estazolam. Outcomes were assessed at 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The main questions it aims to answer are:
- Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.
- Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?
Detailed description
The investigators aimed to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia in a multicenter, double-blind, double-dummy, randomized controlled clinical trial. Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]) or self-reported history of disturbed sleep, diagnosis of "deficiency of the heart and the spleen pattern" or "Qi deficiency of the heart and gallbladder pattern" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023, baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8. The exclusion criteria were (1) self-reported allergy symptoms to any of the ingredients; (2) serious physical sickness; (3) a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy; (4) baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;(5) pregnant women; (6) history of drugs or alcohol abuse/dependence; (7) presence of other sleep disorders including sleep apnoea, restless legs syndrome; (8) night, morning or rotating shift work; (9) participation in concurrent clinical trials. The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) score after 4 weeks' treatment. The secondary outcomes were changes in Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine, as well as the occurrence of adverse events after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.
The main questions it aims to answer are:
- Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics usage, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.
- Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment of Compound Ciwujia Granules | Experimental | Drug: Compound Ciwujia Granules group |
| Treatment of estazolam | Active comparator | Drug: Estazolam |
| Combined treatment of Compound Ciwujia Granules and estazolam | Other | Drug: Compound Ciwujia Granules and estazolam |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]);
- self-reported history of disturbed sleep (i.e, all the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, and self-reported total sleep time of ≤6·5 h) on at least three nights per week for at least 3 months before screening;(3) diagnosis of "deficiency of the heart and the spleen pattern" or "Qi deficiency of the heart and gallbladder pattern" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023;
- baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.
Key exclusion criteria (9 listed)
- self-reported allergy symptoms to any of the ingredients;
- serious physical sickness;
- a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy;
- baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;
- pregnant women;
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 |
|---|---|---|
| Compound Ciwujia Granules groupCompound Ciwujia Granules for 4 consecutive weeks combined with placebo of estazolam for 4 consecutive weeks | Drug | Treatment of Compound Ciwujia Granules |
| Estazolamestazolam for 2 consecutive weeks + placebo of estazolam for 2 consecutive weeks combined with placebo of Compound Ciwujia Granules for 4 consecutive weeks | Drug | Treatment of estazolam |
| Compound Ciwujia Granules and estazolamCompound Ciwujia Granules for 4 consecutive weeks combined with estazolam for 2 consecutive weeks+ placebo of estazolam for 2 consecutive weeks | Drug | Combined treatment of Compound Ciwujia Granules and estazolam |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
PSQI score, 0-21, and higher scores mean a poorer sleep quality.
5 secondary outcomes
Insomnia Severity Index (ISI) score
Time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Hamilton Depression Scale (HAMD-17) score
Time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks
Hamilton Anxiety Scale (HAMA-14) score
Time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Flinders Fatigue Scale (FFS) score
Time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks
Occurrence of adverse events
Time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
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 29 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Ciwujia Granules group, Estazolam and Compound Ciwujia Granules and estazolam in people with Insomnia Disorder, run by Hui Zhu.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Gang Chen, PhD (+86-17771811588, 250149875@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) score (time frame: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.). 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 29 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.