MedDataX Logo

Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia

NCT ID: NCT07286838

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. 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?
2. Is Ciwujia Capsules/Compound Ciwujia Granules" a safe method for treating insomnia in adults?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. 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?
2. Is Ciwujia Capsules/Compound Ciwujia Granules" a safe method for treating insomnia in adults?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

insomnia patients

Ciwujia Capsules/Compound Ciwujia Granules

Intervention Type DRUG

Ciwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ciwujia Capsules/Compound Ciwujia Granules

Ciwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* (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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Hui Zhu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hui Zhu

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gang Chen, PhD

Role: CONTACT

[email protected]
+86-17771811588

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HBZY2024-C62-02

Identifier Type: -

Identifier Source: org_study_id