The early phase of type 2 diabetes mellitus
Conditions
Interventions
Treatment group:Basic treatment + Liuwei Dihuang Pill 8#, tid
ginkgo leaf tablets 2#, tid
Control group:Basic Treatment + Similar Liuwei Dihuang Pill placebo 8#, tid
similar ginko leaf tablets plcebo 2#, tid
Sponsors
The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of TCM)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with diagnosis of type 2 diabetes mellitus, and diagnosis of yin deficiency with internal heat and vessel obstruction in TCM syndrome differentiation; 2. Aged between 50 and 75 years old, both males and females can be included; 3. Patients free of chronic complications, or with mild microvascular complications (urinary albumin excretion < 200ug/min or 300mg/d; with mild non-proliferative diabetic retinopathy or free of obvious retinopathy); 4. BP <=160/100 mmHg; 5. BMI = body weight (kg) / height2 (m2) <= 35; 6. No more than 3 hypoglycemic and hypotensive drugs used when included; 7. Informed consents are obtained and patients are willing to take part in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes mellitus and other types of diabetes mellitus or gestational diabetes mellitus; 2. FBG >=16.7 mmol/L; 3. Occurrence of severe acute complications of diabetes mellitus in the latest month, such as ketoacidosis and diabetic hyperosmolar condition; 4. Patients with macrovascular complications, such as myocardial infarction, cerebrovascular accident and angiopathy of lower limbs; 5. Severe primary heart, hepatic, lung, renal and hematologic disease or other severe disease affecting the survival, such as tumor or AIDS; renal dysfunction; urine protein >+; urinary red cell morphology under microscope >+ (urine Hb is not used); ALT >2*N (N: upper normal limit); ECG abnormality with clinical significance; WBC 6.0 mmol/L; 6. Bilateral cataracts affecting fundus photography; 7. Other conditions judged by the trialists that may lower the possibility of including or complicate the including process, and that may influence the follow-up such as the change of work environment; 8. Patients of allergic constitution, such as patients allergic to two or more drugs or food; and patients allergic to the drugs used in the trial; 9. Pregnant or breast-feeding women; 10. Patients who are taking part in other clinical drugs trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of urine microalbumin to creatine;Carotid arterial intima-media thicknes; | — |
Secondary
| Measure | Time frame |
|---|---|
| TC, TG, HDL-C, LDL-C;Ultrasensitive CRP;Diabetes-specific Quality of Life Scale(DQOL);Intercellular adhesion factors;Single nylon filament detection;Glucose metabolic index: FBG, PBG, HbAlc;Quantitative evaluation of TCM syndromes;Ankle/Brachium index (ABI);SBP, DBP; | — |
Countries
China
Contacts
Public ContactJiangyi Yu
Outcome results
None listed