Research on the biological basis of damp-heat syndrome in traditional Chinese medicine for glycolipid metabolic diseases and the mechanism of effective prescriptions intervention efficacy
- Conditions
- Diabetes
- Registration Number
- ITMCTR2024000166
- Lead Sponsor
- Dongzhimen Hospital, Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method blood glucose;Four blood lipid indicators;glycosylated hemoglobin;
- Secondary Outcome Measures
Name Time Method proteomic detection of blood samples;stool sample flora;detection of water molecules in urine samples;metabolomics detection of blood samples;single cell sequencing of blood samples;Traditional Chinese Medicine Syndrome Score;fundus color photograph examination;metabolomic detection of urine samples;Western blot verification of blood samples;detection of inflammatory factors and cytokines in blood samples;tongue color photo examination;proteomic detection of urine samples;Tongue microcirculation image;detection of water molecules in blood samples;