Compound Ciwujia Granules in the Treatment of Insomnia: a Multi-center, Double-blind, Double-dummy, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) score
研究概览
简要总结
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:
- 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.
- Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?
详细描述
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:
- 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.
- Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •(4) baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.
排除标准
- •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;
- •pregnant women;
- •history of drugs or alcohol abuse/dependence;
- •presence of other sleep disorders including sleep apnoea, restless legs syndrome;
- •night, morning or rotating shift work;
- •participation in concurrent clinical trials.
研究组 & 干预措施
Treatment of Compound Ciwujia Granules
干预措施: Compound Ciwujia Granules group (Drug)
Treatment of estazolam
干预措施: Estazolam (Drug)
Combined treatment of Compound Ciwujia Granules and estazolam
干预措施: Compound Ciwujia Granules and estazolam (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) score
时间窗: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.
PSQI score, 0-21, and higher scores mean a poorer sleep quality.
次要结局
- 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.)
研究者
Hui Zhu
Resident Physician
Hubei Hospital of Traditional Chinese Medicine