研究疾病:
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抑郁症;心脾两虚型
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研究疾病代码:
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Target disease:
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depression; insuffispleenciency of heart and spleen
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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1.通过分层随机对照研究,评价健脾解郁方治疗心脾两虚型轻中度抑郁症的疗效和安全性,为抑郁症患者提供有效治疗方案;
2.从HAMD评分、HAMA评分、中医症状积分及血清BDNF的变化,总结和分析健脾解郁方治疗心脾两虚型轻中度抑郁症的作用特点。
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Objectives of Study:
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1.Through a stratified randomized controlled study, evaluate the efficacy and safety of Jianpi Jieyu Decoction in treating mild to moderate depression with deficiency of both heart and spleen, and provide effective treatment options for patients with depression.
2.From HAMD score, HAMA score, TCM symptom score and serum Changes of BDNF, summarize and analyze the characteristics of Jianpi Jieyu Decoction in treating mild to moderate depression with deficiency of both heart and spleen.
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药物成份或治疗方案详述:
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中药组:给予健脾解郁方,健脾解郁方组成为:炙黄芪30g、党参12g、炒白术12g、当归12g、茯神30g、酸枣仁15g、柴胡10g、合欢皮20g、炒栀子10g;每日一剂,早晚各服用1次,每次200ml,由西苑医院煎药室配制。
对照组:给予帕罗西汀(乐友)口服,每次20mg,每日早饭后服用1次,由浙江华海药业股份有限公司生产。两组疗程均为6周。伴严重失眠者,两组均可合用佐匹克隆7.5mg睡前服用,连续使用不超过7天,6周内累计服用不超过14天。
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Description for medicine or protocol of treatment in detail:
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Chinese medicine group: The Jianpi Jieyu Decoction was given. The composition of the Jianpi Jieyu Decoction consisted of: Sunburned Astragalus 30g, Codonopsis 12g, Fried Atractylodes 12g, Angelica 12g, Fushen 30g, Sour Date Seed 15g, Bupleurum 10g, Albizia Bark 20g, Fried Gardenia 10g; One dose a day, once in the morning and evening, 200ml each time, prepared by the decoction room of Xiyuan Hospital.
Control group: Paroxetine (Leyou) was given orally, 20 mg each time, once a day after breakfast, produced by Zhejiang Huahai Pharmaceutical Co., Ltd. The course of treatment for both groups was 6 weeks. For patients with severe insomnia, both groups can be combined with Zopiclone 7.5mg taken before bedtime for no more than 7 days, and no more than 14 days in 6 weeks.
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纳入标准:
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1.符合上述西医诊断及中医辨证标准;
2.年龄18-65岁,男女不限;
3.HAMD-17评分为≥17分,≤24分,且抑郁情绪一项≥2分;
4.签署知情同意书。
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Inclusion criteria
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1. Meet the above-mentioned Western medical diagnosis and TCM syndrome differentiation standards;
2. Age 18-65 years old, no gender limit;
3. The HAMD-17 score is >= 17 points, <= 24 points, and the item of depression is >= 2 points;
4. Sign informed consent.
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排除标准:
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1.有自杀倾向,HAMD中自杀项≥2分;
2.合并严重焦虑症状,HAMA≥21分者;
3.有严重或不稳定的心、肝、肾、内分泌、血液等内科疾患者;
4.继发于其它精神疾病或躯体疾病的抑郁发作;
5.双相情感障碍的抑郁发作;
6.5周内服用过帕罗西汀或其他抗抑郁药物者;
7.无人监护或不能按医嘱服药者;
8.过敏体质者;
9.妊娠期或哺乳期妇女者。
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Exclusion criteria:
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1. Suicidal tendency, suicide item in HAMD >= 2 points;
2. With severe anxiety symptoms, HAMA >= 21 points;
3. Patients with serious or unstable heart, liver, kidney, endocrine, blood and other medical diseases;
4. Depressive episodes secondary to other mental or physical diseases;
5. Depressive episodes of bipolar disorder;
6. Those who have taken paroxetine or other antidepressants within 5 weeks;
7. Those who are unsupervised or unable to take medication as prescribed by a doctor;
8. People with allergies;
9. Women who are pregnant or breastfeeding.
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研究实施时间:
Study execute time:
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从From
2016-06-14
至To
2019-12-31
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征募观察对象时间:
Recruiting time:
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从From
2017-12-05
至To
2019-12-24
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