Efficacy and Safety of Modified Suan ZaoRen Tang-TianWang BuXin Dan in the Treatment of Chronic Insomnia: A Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The change in Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled clinical trial. Eligible participants will randomized into either treatment group (CM granules) or placebo group (placebo granules) for 6 weeks, followed by a post-treatment visit at week 9. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) at week 6.
详细描述
Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms.
Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years;
- •Eligible for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, criteria for insomnia disorder. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 nights per week for at least 6 months;
- •Insomnia Severity Index (ISI) total score of at least 8 indicating insomnia at the clinical level;
- •Diagnosed to be Yin deficiency-induced internal heat pattern according to traditional Chinese Medicine (TCM) theory;
- •Able to complete questionnaires and take medications as scheduled; and
- •Voluntary written consent.
排除标准
- •Known nervous system disease (eg, stroke, Parkinson's Disease);
- •Known mental disorders (eg, depression or anxiety) or HADS score 11 or above in any either item;
- •Known sleeping related diseases (eg. sleep apnea, nocturnal myoclonus, restless legs, severe nocturnal enuresis or narcolepsy) that may affect the sleeping quality;
- •Known pharmacologically induced insomnia;
- •With symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturition, and cough;
- •Know treatment to comorbid sleep disorders, such as sleep apnea or narcolepsy;
- •Work on shift or on night shift;
- •Concomitant pharmacological treatment or herbal medicines for insomnia within the past month;
- •Known severe medical conditions, such as cardiovascular, liver, kidney or hematopoietic system disease, diabetes mellitus, cancers, cerebrovascular diseases;
- •Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
- •Known alcohol and / or drug abuse;
- •Known allergic history to any Chinese herbal medicines;
- •Diagnosed to be deficiency of spleen according to TCM theory;
- •Any contraindications for taking Chinese medicines in the opinion of the investigators;
- •Know pregnant or lactating; and
- •Involved in other interventional clinical studies at the same time.
研究组 & 干预措施
mSZT-TBD granules
Modified Suan ZaoRen Tang-TianWang BuXin Dan granules
干预措施: Modified Suan ZaoRen Tang-TianWang BuXin Dan (Drug)
Placebo granules
Placebo granules
干预措施: Placebo (Drug)
结局指标
主要结局
The change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: Week 6
PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).
次要结局
- The change in Pittsburgh Sleep Quality Index (PSQI)(Week 3)
- The change in Insomnia Severity Index (ISI)(Week 3)
- The change in Insomnia Severity Index (ISI)(Week 6)
- The change in Hospital Anxiety and Depression Scale (HADS)(Week 3)
- The change in Hospital Anxiety and Depression Scale (HADS)(Week 6)
- The change in Pittsburgh Sleep Quality Index (PSQI)(Week 9)
- Sleep parameter data(From baseline to week 9.)
- The change in Insomnia Severity Index (ISI)(Week 9)
- The change in Hospital Anxiety and Depression Scale (HADS)(Week 9)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong