研究疾病:
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多囊卵巢综合征
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研究疾病代码:
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Target disease:
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polycystic ovary syndrome
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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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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本研究为随机对照有效性研究,将84例PCOS患者随机分为对照组(安慰剂对照+地屈孕酮)和治疗组(紫萸方+地屈孕酮)各42例,疗程3个月经周期,停药观察6个月。以治疗前、停药3月后月经周期天数为主要疗效评价指标,次要疗效指标为血清性激素水平、AMH、排卵情况、中医证候疗效评价、多毛、痤疮评分、焦虑、抑郁评分、体重指数、胰岛素抵抗指数,血清总胆固醇、甘油三酯、低密度脂蛋白、CRP、IL-6、TNF-α,系统评价紫萸方联合地屈孕酮治疗PCOS的临床疗效。
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Objectives of Study:
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This study is a randomized controlled effectiveness study, 84 patients with PCOS were randomly divided into control group (placebo control + didraprogesterone) and treatment group (ZiYu prescription + didragestrel), with a 3-month menstrual cycle and 6 months of discontinuation and observation. Taking the number of menstrual cycle days before treatment and after 3 months of discontinuation as the main efficacy evaluation index, the secondary efficacy indicators were serum hormone level, AMH, ovulation, TCM efficacy evaluation, hirsutism, acne score, anxiety, depression score, body mass index, insulin resistance index, serum total cholesterol, triglycerides, low-density lipoprotein, CRP, IL-6, TNF-α, systematically evaluated the clinical efficacy of ZiYu prescription combined with didraprogesterone in the treatment of PCOS.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)符合多囊卵巢综合征西医诊断标准和肾虚证中医诊断标准者;
(2)育龄期女性,年龄 18-40岁;
(3)3个月内未服用任何影响月经的药物(如:避孕药、激素类或其它影响胰岛素、血糖、性激素和血脂代谢的药物)及未采用相关治疗手段,且无人工流产记录;
(4)妇科检查及辅助检查:内生殖器官与外生殖器无器质性病变,同时无其他原发性疾病者;
(5)签署患者知情同意书。
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Inclusion criteria
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(1) It meets the diagnostic criteria of Western medicine for polycystic ovary syndrome and the diagnostic criteria of traditional Chinese medicine for renal deficiency;
(2) Between the ages of 18 and 40.
(3) Have not taken any drugs that affect menstruation (such as contraceptives, hormones or other drugs that affect insulin, blood glucose, sex hormones and lipid metabolism) within 3 months and have not used relevant treatment methods, and have no record of induced abortion;
(4) Gynecological examination and auxiliary examination: there are no organic lesions of internal and external genitalia, and there are no other primary diseases;
(5) Sign the patient's informed consent form.
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排除标准:
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(1)患者的生殖系统中存在先天不足不能符合本研究需求。
(2)患者具有先天遗传行性精神疾病。
(3)患者肝、心、肾、造血系统等人体器官功能出现衰竭。
(4)患者的体质特殊,对药物有严重的过敏史。
(5)不能按照本研究方案执行的患者。
(6)除此疾病外患者还需进行其它方面的治疗,可能对本研究产生影响的患者。
(7)妊娠或哺乳期妇女。
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Exclusion criteria:
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(1) The presence of congenital deficiencies in the patient's reproductive system cannot meet the needs of this study.
(2) The patient has a congenital inherited mental illness.
(3) The patient's liver, heart, kidney, hematopoietic system and other human organ functions are failed.
(4) The patient has a special physique and has a history of serious allergies to the drug.
(5) Patients who cannot be performed according to this study protocol.
(6) Patients with other diseases need to undergo other aspects of treatment, and patients who may have an impact on this study.
(7) Pregnant or lactating women.
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研究实施时间:
Study execute time:
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从From
2022-01-01
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-09-01
至To
2024-06-30
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