ITMCTR2200005519尚未招募4 期
Clinical trial of Zhen Shu Tiu Zhi Capsule in treating diabetic damp heat syndrome and study on biological basis of damp heat syndrome of glycolipid metabolic diseases
Dongzhimen Hospital, Beijing University of 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
- 4 期
- 状态
- 尚未招募
- 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
- 性别
- All
入选标准
- •Clinical trial of Zhen Shu Tiu Zhi Capsule in treating diabetic damp heat syndrome
- •? 40 = age = 75, regardless of gender;
- •? meet the diagnostic criteria for the guideline for prevention and treatment of type 2 diabetes in China (2020 Edition): typical diabetes symptoms (drink, polyp, polyuria, weight loss due to unknown cause) and satisfy any conditions: (1) random blood glucose is equal to 11.1mmol/L; (2) Fasting blood glucose = 7.0 mmol / L; (3) Blood glucose = 11.1mmol/l 2h after 75g glucose load; (4)HbA1c=6.5% (Note: fasting blood glucose test should be at least 8h not eating calories; no typical diabetes symptoms need to be re examined and confirmed, at least two abnormal blood sugar can be diagnosed).
- •? Diagnostic criteria of TCM symptoms: necessary symptoms: yellow and greasy tongue coating; Visible symptoms: heavy limb sleepiness, dry mouth, bitter mouth, fullness of abdominal distension, less food, stupidity, sticky stool and slippery pulse string. Damp heat syndrome is diagnosed if one must see symptom + one or more visible symptoms are met (pulse is only recorded, not used as the judgment standard); Each symptom was divided into four grades: 0, 1, 2 and 3 according to the severity;
- •? Regular hypoglycemic regimen can meet the requirements of fasting blood glucose < 9.0mmol/l or HbA1c < 8%;
- •? There was no lipid-lowering drug treatment in recent 2 weeks, and the blood pressure level did not exceed 160 / 100mmhg;
- •? Patients had good compliance and signed informed consent;
- •Study on biological basis of damp heat syndrome of glycolipid metabolic diseases
- •?there were 20 patients who met the diagnostic criteria of type 2 diabetes and TCM criteria for non dampness heat syndrome.? Conforms to the diagnostic criteria of damp heat syndrome of Chinese medicine and one of the diagnostic criteria for obesity or hyperlipidemia, and the subjects have no risk factors for type 2 diabetes, namely, fasting plasma glucose level < 100 mg/dL, glycosylated hemoglobin (HbA1c) < 5.7% (normal glucose metabolism), 20 cases. ? There were 20 healthy people. 40 = age = 75, regardless of gender, sign informed consent.
排除标准
- •Clinical trial of Zhen Shu Tiu Zhi Capsule in treating diabetic damp heat syndrome
- •?diagnosis of type 1 diabetes mellitus and other types of non 2 diabetes mellitus;
- •?in the past 6 months, there were diabetic ketosis, non ketosis hyperosmolar diabetic coma, myocardial infarction, cerebrovascular accident, and malignant hypertension.
- •? Allergic or intolerant to Zhenzhu Tiaozhi capsule or its components;
- •? Complicated with serious primary diseases of respiratory, digestive, blood and circulatory systems, as well as current serious infection and mental diseases;
- •? Patients with chronic gastrointestinal diseases or chronic malnutrition, anemia or abnormal hemoglobin diseases;
- •? Transaminase ast or ALT was greater than 2 times of the upper limit of normal, and blood creatinine or blood urea nitrogen was greater than the upper limit of normal;
- •? Pregnant or lactating women and women planning pregnancy;
- •? Patients who have participated in other drug clinical trials or are participating in other clinical trials within 3 months before participating in this trial;
- •? Taking drugs that may affect intestinal flora in recent 2 months, such as antibiotics, berberine, defecation drugs, bifidobacteria, gastrointestinal motility drugs, etc;
- •? Those who had received external enema therapy within 1 month were sampled.
- •Study on biological basis of damp heat syndrome of glycolipid metabolic diseases
- •Patients with primary diseases of heart, liver, kidney, endocrine system or acute and chronic gastrointestinal diseases; Patients with mental illness; Pregnant or lactating patients; Taking drugs that may affect intestinal flora in recent 2 months, such as antibiotics, berberine, defecation drugs, bifidobacteria, etc; Those who had received external enema therapy within 1 month were sampled.
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