ITMCTR2100004380招募中1 期
Evaluating Clinical Effectiveness of Acupuncture for Perimenopausal Depression (PMD) accompanying Insomnia
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 45 至 55（—）
- 性别
- Female
入选标准
- •(1) Aged 45-55 years;
- •(2) Experiencing the perimenopausal phase;
- •(3) Meeting the International Classification of Diseases-Ten Edition (ICD-10) diagnostic criteria for mild or moderate depressive episode and International Classification of Sleep Disorders-Third Edition (ICSD-3) diagnostic criteria for insomnia; Minimum duration of the depression episode accompanying insomnia is about four weeks;
- •(4) 8 points <= HAMD-17 <= 23 points;
- •(5) PSQI > 5 points;
- •(6) In accordance with the diagnostic criteria for Depression of Liver and Deficiency of Kidney in TCM theory;
- •(7) Volunteering to join this trial and sign a written informed consent form.
排除标准
- •(1) Belong to non-natural menopause transition due to premature ovarian failure, medication intake, or surgery (e.g., oophorectomy);
- •(2) Are pregnant or currently lactating;
- •(3) Depression or insomnia is caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.);
- •(4) Are diagnosed as severe depressive episode according to ICD-10 and/or have ideas or acts of suicide;
- •(5) Had a depressive disorder diagnosis prior to perimenopausal phase;
- •(6) Comorbid with other psychiatric and mental disorders, other depression-related disorder, or sleep-related disorders diagnosed by DSM-V and ICD-10 in addition to depression and insomnia;
- •(7) Take medications (e.g., antidepressant, hypnotic, other psychotropic substances, Chinese herbal medicine, etc.) and/or health care products (e.g., melatonin, black cohosh, etc.), or receive other therapies (e.g., CBT, Mindfulness-Based Exercise, etc.) that are intended to treat depression and insomnia within the last one month prior to the commencement of this trial;
- •(8) Receive hormones therapy within the last two months prior to the commencement of this trial;
- •(9) Had acupuncture treatment experience in the past 3 months;
- •(10) Have an infection close to the position of the specified acupoints;
- •(11) Have any serious physical illness (such as serious cardiovascular, lung, liver, and kidney diseases, etc.);
- •(12) With alcohol or drug abuse/addiction;
- •(13) Have participated in any clinical trial in the last three months;
- •(14) With other conditions which makes them an unsuitable candidate for this trial.
研究者
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