Health TrialsbyHealthPanel

Compound Ciwujia Granules in the Treatment of Insomnia

ConditionInsomnia Disorder
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorHui Zhu

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Compound Ciwujia Granules group

    Drug

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

  • 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

  • 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

Treatment groups

1,200 Participants
are divided into 3 treatment groups
Group A: Treatment of Compound Ciwujia GranulesExperimental treatment 1 intervention
Group B: Treatment of estazolamActive comparator 1 intervention
Group C: Combined treatment of Compound Ciwujia Granules and estazolamOther 1 intervention

Trial outcomes

Primary outcomes

1

Pittsburgh Sleep Quality Index (PSQI) score

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

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

Secondary outcomes

1

Insomnia Severity Index (ISI) score

ISI score, 0-28, and higher scores mean a worse sleep problem

Time frame
From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
2

Hamilton Depression Scale (HAMD-17) score

HAMD-17 score, 0-55, and higher scores mean more severe depression.

Time frame
From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks
3

Hamilton Anxiety Scale (HAMA-14) score

HAMA-14 score, 0-56, and higher scores mean more severe anxiety

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

Flinders Fatigue Scale (FFS) score

FFS score, 0-31, and higher scores mean more severe fatigue

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

Other outcomes

1

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.

Time frame
From enrollment to the end of treatment at 4 weeks
2

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.

Time frame
From enrollment to the end of treatment at 4 weeks
3

Insomnia pattern score of traditional Chinese medicine

Insomnia pattern score of traditional Chinese medicine, 0-41, and higher scores mean a worse sleep problem

Time frame
From enrollment to the end of treatment at 4 weeks
4

Use of sedatives and hypnotics

If it exists, provide information on the use of sedatives or hypnotics (e.g. drug names, dose, and duration)

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hui Zhu

Lead sponsor

Hubei Hospital of Traditional Chinese Medicine

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: