Compound Ciwujia Granules in the Treatment of Insomnia

Compound Ciwujia Granules in the Treatment of Insomnia: a Multi-center, Double-blind, Double-dummy, Randomized Controlled Trial

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia Disorder
• Intervention / Treatment: Drug: Compound Ciwujia Granules group; Drug: Estazolam; Drug: Compound Ciwujia Granules and estazolam

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?

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gang Chen, PhD; Phone Number: +86-17771811588; Email: 250149875@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment of Compound Ciwujia Granules	Drug: Compound Ciwujia Granules group; Compound Ciwujia Granules for 4 consecutive weeks combined with placebo of estazolam for 4 consecutive weeks
Active Comparator: Treatment of estazolam	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
Other: Combined treatment of Compound Ciwujia Granules and estazolam	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI) score	ISI score, 0-28, and higher scores mean a worse sleep problem	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	HAMD-17 score, 0-55, and higher scores mean more severe depression.	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	HAMA-14 score, 0-56, and higher scores mean more severe anxiety	From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
Flinders Fatigue Scale (FFS) score	FFS score, 0-31, and higher scores mean more severe fatigue	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep diary	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 4 weeks
Constitution classification of traditional Chinese medicine	Constitution classification score of traditional Chinese medicine, 0-100, and higher scores mean more likely to have the specified constitution classification.	From enrollment to the end of treatment at 4 weeks
Insomnia pattern score of traditional Chinese medicine	Insomnia pattern score of traditional Chinese medicine, 0-41, and higher scores mean a worse sleep problem	From enrollment to the end of treatment at 4 weeks
Use of sedatives and hypnotics	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 4 weeks, and follow-up at 8 weeks, and 12 weeks.

Collaborators and Investigators

• Sponsor: Hui Zhu

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; insomnia; multicenter; Compound Ciwujia Granules
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Estazolam
• Other Study ID Numbers: HBZY2024-C61-03

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