Clinical effect of Baihu and Renshen Decoction on diabetic ketosis and diabetic ketoacidosis
- Conditions
- Diabetic ketosis and Diabetic ketoacidosis
- Registration Number
- ITMCTR1900002742
- Lead Sponsor
- Shenzhen Tradictional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the diagnosis of diabetic ketosis and diabetic ketoacidosis in the Chinese hyperglycemic crisis diagnosis and treatment guidelines formulated by the diabetes branch of the Chinese Medical Association in 2013;
2. It conforms to the diagnosis of deficiency of yin and excessive heat syndrome of diabetes in the clinical research guide of new Chinese medicine;
3. Aged >= 16 and < 70 years;
4. Not participated in any intervention clinical research in the past 3 months;
5. Informed understanding of this study, and voluntarily signed a written informed consent.
1. Ketosis and ketoacidosis caused by hunger ketosis, alcohol ketoacidosis and other reasons;
2. Metabolic acidosis caused by serious infection, chronic kidney disease, renal tubular acidosis and other reasons;
3. Hyperlactatemia and acidosis caused by any reason;
4. Hypertonic state caused by high fever, sweating, gastrointestinal fluid loss, renal diabetes insipidus, water source disconnection, thirst disorder, dysphagia and other reasons;
5. Serious chronic diabetic complications: diabetic nephropathy state in G3aA2 and above, severe nonproliferative and proliferative retinopathy, diabetic lower extremity angiopathy ABI less than or equal to 0.9 or Fontaine's stage IIA and above, diabetic foot, etc;
6. Uncontrolled hypertension, systolic blood pressure > 160mmHg and / or diastolic blood pressure > 100mmHg;
7. Chronic kidney disease: eGFR < 60ml / min / 1.73m2, serum creatinine > 133 µ mol / L (1.5mg / dl); serious liver function abnormality (liver enzyme > 3uln; coagulation function abnormality; bilirubin abnormality); serious heart function abnormality: heart failure (above NYHA III), myocardial infarction, arrhythmia, etc.; acute stage of cerebrovascular disease;
8. Malignant diseases under treatment or not completely relieved or cured;
9. Pregnant or lactational period women;
10. Allergic to any ingredients in Baihu and Renshen Decoction;
11. The researcher thinks it is not suitable to participate in the study (mental or psychological state, etc.).
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood ketone;Blood Gas Analysis;Urine ketone;
- Secondary Outcome Measures
Name Time Method