Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia

NCT07286838 | Not Yet Recruiting DMC

• 1 other identifier: HBZY2024-C62-02
• Study Type: observational
• Target: 40,000
• Locations: 0 countries
• Sites: N/A

Brief 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. The main question it aims to answer is:

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

Conditions

Insomnia Disorders

Keywords

Ciwujia Capsules/Compound Ciwujia Granules; Insomnia; real-world study

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) score

  0-21, and higher scores mean a poorer sleep quality

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Insomnia Severity Index (ISI) score

  From enrollment to the end of treatment at 8 weeks

• occurrence of adverse events

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (2)

• Sleep diary

  From enrollment to the end of treatment at 8 weeks

• Sedatives or hypnotics use

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

insomnia patients

Drug: Ciwujia Capsules/Compound Ciwujia Granules

Interventions

Ciwujia Capsules/Compound Ciwujia Granules DRUG

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

insomnia patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Hui Zhu: lead
• Huazhong University of Science and Technology: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Siberian ginseng root

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Gang Chen, PhD

CONTACT

+86-17771811588; 250149875@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share