研究疾病:
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糖尿病
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研究疾病代码:
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Target disease:
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Diabetes
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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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上市后药物
Post-marketing clinical trial
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研究目的:
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运用随机、双盲临床试验设计方法,探索贞术调脂胶囊治疗糖尿病湿热证的临床疗效与机制,通过贞术调脂胶囊治疗糖尿病湿热证的单中心小样本随机双盲对照试验,验证贞术调脂胶囊治疗糖尿病湿热证的临床疗效与机制。
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Objectives of Study:
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To explore the clinical efficacy and mechanism of Zhenshu Tiaozhi Capsules in the treatment of diabetes with damp-heat syndrome by using a randomized, double-blind clinical trial design method. And the clinical efficacy and mechanism of Zhenzhu Tiaozhi Capsule in the treatment of diabetic damp-heat syndrome were verified through a single-center, small-sample, randomized, double-blind controlled trial of Zhenzhu Tiaozhi Capsule in the treatment of diabetic damp-heat syndrome.
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药物成份或治疗方案详述:
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中药治疗组予基础治疗+贞术调脂胶囊,对照组予基础治疗+等剂量中药安慰剂,均为4粒/次,3次/日持续治疗3个月。其中,贞术调脂胶囊的药物组成为:酒女贞子、佛手、盐杜仲、麸炒白术、三七、丹参、大蓟、黄连。中药安慰剂由淀粉组成。
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Description for medicine or protocol of treatment in detail:
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The traditional Chinese medicine treatment group was given basic treatment + Zhenzhu Tiaozhi capsule, and the control group was given basic treatment + equal dose of traditional Chinese medicine placebo, both 4 capsules/time, 3 times/day for 3 months. Among them, the medicinal composition of Zhenshu Tiaozhi Capsule is: Ligustrum lucidum, bergamot, salt Eucommia, bran fried Atractylodes, Panax notoginseng, Salvia miltiorrhiza, Daji, Coptis chinensis. The traditional Chinese medicine placebo consists of starch.
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纳入标准:
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(1)18≤年龄≤75,性别不限;
(2)符合《中国2型糖尿病防治指南(2020版)》诊断标准:典型糖尿病症状(多饮、多食、多尿、原因不明的体重下降)并满足一下任一条件:
1)随机血糖≥11.1mmol/L;
2)空腹血糖≥7.0 mmol/L;
3)75g葡萄糖负荷后2h血糖≥11.1mmol/L;
4)HbA1c≥6.5%。(注:空腹血糖检测需至少8h未进食热量;无典型糖尿病症状者需改日复查确认,至少两次血糖异常方能诊断);
(3)中医症候诊断标准:必见症:舌苔黄腻;可见症:肢体困重,口干口苦,脘腹胀满,食少纳呆,大便粘腻,脉弦滑。符合1条必见症+1条及以上可见症者即诊断为湿热证(脉象仅作记录,不作为判定标准);每项症状按照程度轻重分为0,1,2,3共四个评分等级;
(4)规律降糖方案治疗,满足空腹血糖<9.0mmol/L或HbA1C <8%;
(5)近2周未进行调脂药物治疗,血压水平不超过160/100mmHg;
(6)签署知情同意书。
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Inclusion criteria
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(1) Aged 40-75 years, gender is not limited;
(2) Meet the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition): typical symptoms of diabetes (polydipsia, polyphagia, polyuria, unexplained weight loss) and meet any of the following conditions:
1) Random blood sugar >=11.1mmol/L;
2) Fasting blood glucose >=7.0 mmol/L;
3) 2h blood glucose >=11.1mmol/L after 75g glucose load;
4) HbA1c>=6.5%. (Note: Fasting blood glucose test requires at least 8 hours without eating calories; those without typical symptoms of diabetes need to be re-examined for confirmation on another day, and at least two abnormal blood sugar can be diagnosed);
(3) Diagnostic criteria of TCM symptoms: mandatory symptoms: yellow and greasy tongue coating; visible symptoms: heavy limbs, dry mouth and bitter taste, abdominal distention, lack of appetite, sticky stool, slippery pulse. Those who meet 1 must-see symptom + 1 or more visible symptoms are diagnosed as damp-heat syndrome (the pulse condition is only recorded and not used as a judgment standard); each symptom is divided into four grades of 0, 1, 2, and 3 according to the severity;
(4) Regular hypoglycemic treatment, satisfying fasting blood glucose <9.0mmol/L or HbA1C <8%;
(5) No lipid-lowering drug treatment in the past 2 weeks, blood pressure level does not exceed 160/100mmHg;
(6) Sign the Informed Consent Form.
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排除标准:
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(1)确诊1型糖尿病及其他类型等非2型糖尿病者;
(2)近6个月内有糖尿病酮症、非酮症高渗性糖尿病昏迷、心肌梗死、脑血管意外、恶性高血压等危急重症病史者;
(3)贞术调脂胶囊或其组分过敏者或不耐受者;
(4)合并严重呼吸、消化、血液、循环等系统原发疾病及目前严重感染、精神疾病者;
(5)慢性胃肠疾病或慢性营养不良,有贫血或血红蛋白异常疾病的患者;
(6)转氨酶AST或ALT大于正常上限的2倍,血肌酐或血尿素氮大于正常上限;
(7)妊娠期或哺乳期妇女及计划妊娠的妇女;
(8)在参加本试验前3个月内曾参加其他药物临床试验或正在参加其他临床试验的患者;
(9)近2个月服用可能影响肠道菌群药物者,如抗生素、黄连素、通便药物、双歧杆菌、胃肠动力药等;
(10)采样1月内接受过外用灌肠疗法者。
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Exclusion criteria:
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(1) Patients diagnosed with type 1 diabetes and other types of non-type 2 diabetes;
(2) Those who have a history of critical illness such as diabetic ketosis, non-ketotic hyperosmolar diabetic coma, myocardial infarction, cerebrovascular accident, malignant hypertension, etc. in the past 6 months;
(3) Those who are allergic or intolerant to Zhenzhu Tiaozhi Capsule or its components;
(4) Those with severe respiratory, digestive, blood, circulatory and other systemic primary diseases and current serious infections and mental illnesses;
(5) Patients with chronic gastrointestinal disease or chronic malnutrition, anemia or abnormal hemoglobin disease;
(6) Transaminases AST or ALT are greater than 2 times the upper limit of normal, and serum creatinine or blood urea nitrogen is greater than the upper limit of normal;
(7) Pregnancy or lactation and planned pregnancy;
(8) Patients who have participated in clinical trials of other drugs or are participating in other clinical trials within 3 months before participating in this trial;
(9) Those who have taken drugs that may affect the intestinal flora in the past 2 months, such as antibiotics, berberine, laxatives, bifidobacteria, gastrointestinal motility drugs, etc.;
(10) Those who have received external enema therapy within 1 month of sampling.
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研究实施时间:
Study execute time:
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从From
2022-08-23
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
2022-08-23
至To
2024-02-27
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