Trials Sponsors Conditions Drugs Pricing

Conditions

Insomnia Disorder

Keywords

Compound Ciwujia Granulesmulticenterrandomized controlled trialinsomnia

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
+1 more other outcomes

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 groupDrug

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

Treatment of Compound Ciwujia Granules

EstazolamDrug

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

Eligibility Criteria

Age40 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Hui Zhu
Otherlead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Estazolam

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Compound Ciwujia Granules in the Treatment of Insomnia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (4)

Study Arms (3)

Treatment of Compound Ciwujia Granules

Treatment of estazolam

Combined treatment of Compound Ciwujia Granules and estazolam

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (4)

Study Arms (3)

Treatment of Compound Ciwujia Granules

Treatment of estazolam

Combined treatment of Compound Ciwujia Granules and estazolam

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record