Insomnia DisordersNCT07286838
Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia
An observational study of Insomnia Disorders, run by Hui Zhu.
Trial summary
The goal of this real-world study is to investigate the efficacy and safety of "Ciwujia Capsules/Compound Ciwujia Granules" in the treatment of insomnia in the clinical real-world. A total of 40000 patients with insomnia are assigned to 8 weeks of Ciwujia Capsules/Compound Ciwujia Granules treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia Disorders
- What is being tested?
- Ciwujia Capsules/Compound Ciwujia Granules
- Type of treatment
- Pill or oral medicine
- How many people
- 40,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2028
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 40000 patients with insomnia were included in this real-world study. Participants were adults aged 18-75 years old who had insomnia disorder, or self-reported history of disturbed sleep.
Who may be able to join
- adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]), or self-reported history of disturbed sleep.
Who cannot join
- (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) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score.
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: Effects of Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia: a Multicenter, Prospective Real-world Study
The goal of this real-world study is to investigate the efficacy and safety of "Ciwujia Capsules/Compound Ciwujia Granules" in the treatment of insomnia in the clinical real-world. A total of 40000 patients with insomnia are assigned to 8 weeks of Ciwujia Capsules/Compound Ciwujia Granules treatment. The main question it aims to answer is:
- Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules/Compound Ciwujia Granules?
- Is Ciwujia Capsules/Compound Ciwujia Granules" a safe method for treating insomnia in adults?
Read the detailed description
The investigators aimed to investigate the efficacy and safety of "Ciwujia Capsules/Compound Ciwujia Granules" in the treatment of insomnia in the clinical real-world. Eligible participants were adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]), or self-reported history of disturbed sleep. 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) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score. The secondary outcomes were the Insomnia Severity Index (ISI) score, sleep diary, sedatives or hypnotics usage, as well as the occurrence of adverse events at 8 weeks. The main question it aims to answer is:
- Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules/Compound Ciwujia Granules?
- Is Ciwujia Capsules/Compound Ciwujia Granules" a safe method for treating insomnia in adults?
- Conditions
- Insomnia Disorders
- Being tested
- Ciwujia Capsules/Compound Ciwujia Granules
- Keywords
- Ciwujia Capsules/Compound Ciwujia Granules, Insomnia, real-world study
- 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.
Ciwujia Capsules/Compound Ciwujia GranulesDrug
Ciwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind.
| Study group | Role | What they receive |
|---|---|---|
| insomnia patients | Not described Receives: Drug: Ciwujia Capsules/Compound Ciwujia Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI) score
0-21, and higher scores mean a poorer sleep quality
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
Insomnia Severity Index (ISI) score
0-28, and higher scores mean a worse sleep problem
Measured: From enrollment to the end of treatment at 8 weeks
occurrence of adverse events
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor-investigator, Hui Zhu, Hubei Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286838
- Sponsor's protocol ID
- HBZY2024-C62-02
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia: a Multicenter, Prospective Real-world Study
- ClinicalTrials.gov ID
- NCT07286838
- Acronym / sponsor ID
- HBZY2024-C62-02
- Conditions
- Insomnia Disorders
- Keywords
- Ciwujia Capsules/Compound Ciwujia Granules, Insomnia, real-world study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Hui ZhuUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 16 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 real-world study is to investigate the efficacy and safety of "Ciwujia Capsules/Compound Ciwujia Granules" in the treatment of insomnia in the clinical real-world. A total of 40000 patients with insomnia are assigned to 8 weeks of Ciwujia Capsules/Compound Ciwujia Granules treatment. The main question it aims to answer is:
- Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules/Compound Ciwujia Granules?
- Is Ciwujia Capsules/Compound Ciwujia Granules" a safe method for treating insomnia in adults?
Detailed description
The investigators aimed to investigate the efficacy and safety of "Ciwujia Capsules/Compound Ciwujia Granules" in the treatment of insomnia in the clinical real-world. Eligible participants were adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]), or self-reported history of disturbed sleep. 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) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score. The secondary outcomes were the Insomnia Severity Index (ISI) score, sleep diary, sedatives or hypnotics usage, as well as the occurrence of adverse events at 8 weeks. The main question it aims to answer is:
- Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules/Compound Ciwujia Granules?
- Is Ciwujia Capsules/Compound Ciwujia Granules" a safe method for treating insomnia in adults?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insomnia patients | – | Drug: Ciwujia Capsules/Compound Ciwujia Granules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 40000 patients with insomnia were included in this real-world study. Participants were adults aged 18-75 years old who had insomnia disorder, or self-reported history of disturbed sleep.
Key inclusion criteria (1 listed)
- adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM5]), or self-reported history of disturbed sleep.
Key exclusion criteria (1 listed)
- (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) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score.
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 |
|---|---|---|
| Ciwujia Capsules/Compound Ciwujia GranulesCiwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind. | Drug | insomnia patients |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: From enrollment to the end of treatment at 8 weeks
0-21, and higher scores mean a poorer sleep quality
2 secondary outcomes
Insomnia Severity Index (ISI) score
Time frame: From enrollment to the end of treatment at 8 weeks
occurrence of adverse events
Time frame: From enrollment to the end of treatment at 8 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 16 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?
An observational study of Insomnia Disorders, 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 1 inclusion and 1 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 16 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.
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 8 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 16 Dec 2025.