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

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

Treatments tested in this trial

Compound Ciwujia Granules group
Estazolam
Compound Ciwujia Granules and estazolam

Treatment groups

1,200 Participants

are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Hui Zhu

Lead sponsor

Hubei Hospital of Traditional Chinese Medicine

Sponsor institution

Source ClinicalTrials.gov