type 2 diabetes
Conditions
Interventions
Experiment group:Tangnin Tongluo Capsule, 4 capsules one time, tid, po after meal
placebo group:placebo, 4 capsules one time,tid,po after meal
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the inform consent form before conducting any research procedures; 2. Male, infertile female, fertility female need a medically-licensed, reliable method of contraception: 1) Definition of infertile female: postmenopausal (natural (spontaneous) menopause for more than 12 months); six weeks after bilateral ovariectomy (with / without hysterectomy); after hysterectomy; or after tubal ligation; 2) Definition of fertility female: any female who is physiologically able to have a pregnancy, include females with male sexual partners outside of occupation, lifestyle or sexual orientation, and female whose sexual partners have undergone vasectomy or other sterilization methods; 3) Medically licensed contraceptive method: hormone contraceptives, IUD, and dual contraception. Acceptable methods of contraception include total abstinence. This should be done after the investigator carefully considers the age, occupation, lifestyle or sexual orientation of the subject to ensure compliance. Periodic abstinence (For example, according to the calendar, ovulation, symptom temperature method, post-ovulation method) and ejaculation in vitro are unacceptable methods of contraception. 3. Aged 18 to 70 years old; 4. HbA1c >7.5% and ?10.0%, When the subject is selected; 5. Diagnosed as type 2 diabetes, have not received any hypoglycemic drugs in the past and after 3 months of diet exercise, blood glucose is still poorly controlled or have received short-term hypoglycemic drugs (<1 month) and have stopped medication for more than 3 months; 6. BMI 18-35 kg/m^2.
Exclusion criteria
Exclusion criteria: 1. Female who are pregnant or breast-feeding and female who are pregnant do not take appropriate methods of contraception to avoid pregnancy; 2. Have the following medical history; 1) Suffering from type 1 diabetes, diabetes caused by pancreatic injury, or secondary diabetes, such as Cushing syndrome or acromegaly, etc.; 2) Acute complications of diabetes: in the past six months have ketoacidosis or hyperosmolar nonketotic coma. 3) Received systemic corticosteroids (oral or intravenous) therapy for 7 consecutive days in the past 6 months. 4) Have any of the following characteristics who with clinically significant liver disease: (1) Within four weeks before screening, two consecutive measurements of liver function abnormalities, alanine aminotransferase (ALT) and aspartate transaminase (AST) measurements are three times the upper limit of normal. (2) Excretory disorders (such as High bilirubinemia) and/or synthetic dysfunction or other symptoms of decompensated liver diseasesuch as coagulopathy, hepatic encephalopathy, hypoproteinemia ascites and oesophageal varices bleeding (3) Acute viral or active autoimmunity, alcohol or other types of hepatitis. 3. Within 4 weeks before screening or examinationmoderate/severe patients with renal injury or end stage renal disease (Creatinine > 194.5 µmol/L or K+ > 5.5 mmol/L); 4. New York Heart Association (NYHA) Class III or IV Congestive Heart Failure; 5. Have a significant history of cardiovascular disease within the past three months, defined as: History of myocardial infarction; coronary angioplasty or bypass surgery; valvular disease; repair, unstable angina; transient ischemic attack; cerebrovascular accident acute and Chronic pancreatitis; 6. Have been diagnosed with cancer or in therapy in the past five years; 7. History of organ transplantation or acquired immunodeficiency syndrome (AIDS); 8. A history of alcohol abuse or drug abuse in the past 12 months; 9. Potentially unreliable patient or the investigator believes the patient are not suitable for this trial; 10. Tradition Chinese medicine (TCM) diagnosis in patients with diarrhea and weakness of the spleen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard meal fasting blood glucose;2 hours of plasma glucose after breakfast;Standard meal test insulin;C-Peptide;Blood routine and urine routine;Liver and kidney function; | — |
Countries
China
Contacts
Public ContactYiming Mu
Chinese PLA General Hospital
Outcome results
None listed