Compound Ciwujia Granules in the Treatment of Insomnia

NCT ID: NCT07306494

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-06-30

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

Detailed Description

The investigators aimed to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia in a multicenter, double-blind, double-dummy, randomized controlled clinical trial. 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]) or self-reported history of disturbed sleep, 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, baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8. 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) night, morning or rotating shift work; (9) participation in concurrent clinical trials. The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) score after 4 weeks' treatment. The secondary outcomes were changes in 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, as well as the occurrence of adverse events after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.

The main questions it aims to answer are:

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 usage, 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment of Compound Ciwujia Granules

Group Type: EXPERIMENTAL

Compound Ciwujia Granules group

Intervention Type: DRUG

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

Treatment of estazolam

Group Type: ACTIVE_COMPARATOR

Estazolam

Intervention Type: DRUG

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

Combined treatment of Compound Ciwujia Granules and estazolam

Group Type: OTHER

Compound Ciwujia Granules and estazolam

Intervention Type: DRUG

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

Interventions

Compound Ciwujia Granules group

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

Intervention Type: DRUG

Estazolam

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

Intervention Type: DRUG

Compound Ciwujia Granules and estazolam

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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]);

2. 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.

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. night, morning or rotating shift work;

9. participation in concurrent clinical trials.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui Zhu

OTHER

Sponsor Role: lead

Responsible Party

Hui Zhu

Resident Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Gang Chen, PhD

Role: CONTACT

Phone: +86-17771811588

Email: 250149875@qq.com

Other Identifiers

HBZY2024-C61-03

Identifier Type: -

Identifier Source: org_study_id