Compound Ciwujia Granules in the Treatment of Insomnia

NCT07306494 | Not Yet Recruiting Phase 4

• 1 other identifier: HBZY2024-C61-03
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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:

1. 1.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.
2. 2.Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?

Conditions

Insomnia Disorder

Keywords

Compound Ciwujia Granules; multicenter; randomized controlled trial; insomnia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) score

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

  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

  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

  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

  From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.

• Flinders Fatigue Scale (FFS) score

  From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks

• Occurrence of adverse events

  From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.

Other Outcomes (4)

• Sleep diary

  From enrollment to the end of treatment at 4 weeks

• Constitution classification of traditional Chinese medicine

  From enrollment to the end of treatment at 4 weeks

• Insomnia pattern score of traditional Chinese medicine

  From enrollment to the end of treatment at 4 weeks

Study Arms (3)

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

Interventions

Compound Ciwujia Granules group DRUG

Compound Ciwujia Granules for 4 consecutive weeks combined with placebo of estazolam for 4 consecutive weeks

Treatment of Compound Ciwujia Granules

Estazolam DRUG

estazolam for 2 consecutive weeks + placebo of estazolam for 2 consecutive weeks combined with placebo of Compound Ciwujia Granules for 4 consecutive weeks

Treatment of estazolam

Compound Ciwujia Granules and estazolam DRUG

Compound Ciwujia Granules for 4 consecutive weeks combined with estazolam for 2 consecutive weeks+ placebo of estazolam for 2 consecutive weeks

Combined treatment of Compound Ciwujia Granules and estazolam

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• (4) baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.

You may not qualify if:

• 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;
• presence of other sleep disorders including sleep apnoea, restless legs syndrome;
• night, morning or rotating shift work;
• participation in concurrent clinical trials.

Sponsors & Collaborators

• Hui Zhu: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Estazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Gang Chen, PhD

CONTACT

+86-17771811588; 250149875@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share