Compound Ciwujia Granules in the Treatment of Insomnia

Официальное название

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

Обзор

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?

Подробное описание

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?

Вмешательства

• Препарат Compound Ciwujia Granules group
  Compound Ciwujia Granules for 4 consecutive weeks combined with placebo of estazolam for 4 consecutive weeks
• Препарат Estazolam
  estazolam for 2 consecutive weeks + placebo of estazolam for 2 consecutive weeks combined with placebo of Compound Ciwujia Granules for 4 consecutive weeks
• Препарат 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

Первичные конечные точки

• Pittsburgh Sleep Quality Index (PSQI) score [Срок оценки: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.]

Вторичные конечные точки (5)

• Insomnia Severity Index (ISI) score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.]
• Flinders Fatigue Scale (FFS) score [Срок оценки: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks]
• Occurrence of adverse events [Срок оценки: From enrollment to the end of treatment at 4 weeks, and follow-up at 8 weeks and 12 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07306494 · HBZY2024-C61-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗