Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia

December 13, 2025 updated by: Hui Zhu

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:

  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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  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?

Study Type

Observational

Enrollment (Estimated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
insomnia patients
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI) score
Time Frame: From enrollment to the end of treatment at 8 weeks
0-28, and higher scores mean a worse sleep problem
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
From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep diary
Time Frame: From enrollment to the end of treatment at 8 weeks
providing daily information on subjective sleep onset latency, subjective total sleep time, subjective sleep quality, subjective wake after sleep onset, and subjective number of awakenings.
From enrollment to the end of treatment at 8 weeks
Sedatives or hypnotics use
Time Frame: From enrollment to the end of treatment at 8 weeks
If it exists, provide information on the use of sedatives or hypnotics (e.g. drug names, dose, and duration)
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Zhu

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBZY2024-C62-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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