Status:
UNKNOWN
Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia
Detailed Description
Waist circumference, body mass index, triglycerides, glycosylated hemoglobin, blood glucose were evaluated; liver function, kidney function, blood, urine, stool, adverse event recording, evaluation of...
Eligibility Criteria
Inclusion
- signed informed consent;
- waistline male ≥ 90cm, female ≥ 80cm;
- According to the 1999 WHO standards, meet diagnostic criteria for type 2 diabetes onset and untreated patients, after a screening period (diet + exercise therapy 4 weeks) after the fasting plasma glucose ≥ 7.0mmol • L-1, but fasting blood glucose \<13.9mmol • L-1, or 2h postprandial blood glucose ≥ 11.1mmol • L-1; and glycated hemoglobin ≥ 7.0%;
- After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG \<5.65mmol / L;
- TCM for the heat of the gastrointestinal;
- Age 30-65 years old.
Exclusion
- Patients has been used insulin therapy; previously had a continuous period of 3 months or longer treatment of diabetes(including other Chinese and Western medicine, physical therapy, psychological therapy and health food, etc.) ; enrolled within 1 month before the use of blood glucose and lipids drug treatment;
- Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases;
- Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons;
- Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections;
- Patients with mental illness;
- Pregnancy, pregnancy or breast-feeding women to prepare;
- Patients with Chinese medicine allergies; and allergy;
- Patients with had participated in this study within 1 month have participated or are participating in other clinical studies;
- In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence;
- According to the researchers to determine, with the possibility of lower income group or the other into a complex set of diseases or conditions, such as work environment, frequent changes in unstable living environment, the situation could easily lead to lost;
- Patients taking the dose and type of antihypertensive drugs can not remain stable;
- Patients taking drugs that affect the quality of the body or health food.
- Patients with liver, impaired renal function (ALT, AST greater than 2 times the upper limit of normal; serum creatinine greater than the upper limit of normal);
- Patients are known to lower blood sugar for those who are asymptomatic.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01471275
Start Date
November 1 2011
End Date
December 1 2013
Last Update
December 6 2011
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Guang'anmen Hospital of China Academy ofChinese Medical Sciences
Beijing, Beijing Municipality, China
2
Baoding Hospital of TCM
Baoding, Hebei, China
3
Affiliated Hospital of Changchun University of TCM
Changchun, Jilin, China
4
Qinghai Provence Hospital of TCM
Xining, Qinghai, China