Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia | RxWiki

Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

Overview[ - collapse ][ - ]

Purpose	With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia
Condition	Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
Intervention	Drug: Metformin Drug: Jiangtangtiaozhi decoction
Phase	N/A
Sponsor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible Party	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier	NCT01471275
First Received	November 14, 2011
Last Updated	December 5, 2011
Last verified	December 2011

Tracking Information[ + expand ][ + ]

First Received Date	November 14, 2011
Last Updated Date	December 5, 2011
Start Date	November 2011
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Glycosylated hemoglobin [Time Frame: 12 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Waistline [Time Frame: 4 weeks] [Designated as safety issue: No] Triglycerides [Time Frame: 12 weeks] [Designated as safety issue: No] Liver function [Time Frame: 4 weeks] [Designated as safety issue: Yes] Renal function [Time Frame: 4 weeks] [Designated as safety issue: Yes] Whole blood cell analysis [Time Frame: 4 weeks] [Designated as safety issue: Yes] Urinalysis [Time Frame: 12 weeks] [Designated as safety issue: Yes] Adverse events recorded [Time Frame: 4 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
Official Title	The Study of TCM in Prevention and Promote of Community-based Diabetes
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 low blood sugar event log security.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
Intervention	Drug: Metformin 250 mg or 500mg three times a day Other Names: Metformin enteric-coated tablets.Drug: Jiangtangtiaozhi decoction 15 grams each time, twice a day, with boiled water Other Names: a decoction make of 8 herbs
Study Arm (s)	Experimental: Jiangtangtiaozhi decoction Active Comparator: metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	450
Estimated Completion Date	December 2013
Estimated Primary Completion Date	September 2013
Eligibility Criteria	Inclusion Criteria: 1. signed informed consent; 2. waistline male ≥ 90cm, female ≥ 80cm; 3. 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%; 4. After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG <5.65mmol / L; 5. TCM for the heat of the gastrointestinal; 6. Age 30-65 years old. Exclusion Criteria: 1. 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; 2. Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases; 3. Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons; 4. Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections; 5. Patients with mental illness; 6. Pregnancy, pregnancy or breast-feeding women to prepare; 7. Patients with Chinese medicine allergies; and allergy; 8. Patients with had participated in this study within 1 month have participated or are participating in other clinical studies; 9. In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence; 10. 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; 11. Patients taking the dose and type of antihypertensive drugs can not remain stable; 12. Patients taking drugs that affect the quality of the body or health food. 13. 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); 14. Patients are known to lower blood sugar for those who are asymptomatic.
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Lian Fengmei, doctor lfm565@sohu.com
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01471275
Other Study ID Numbers	368
Has Data Monitoring Committee	Yes
Information Provided By	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators	Not Provided
Investigators	Study Chair: Xiaolin Tong China academy of Chinese medical science
Verification Date	December 2011

Locations[ + expand ][ + ]

Guang'anmen Hospital of China Academy ofChinese Medical Sciences	Beijing, Beijing, China Contact: Zhou Qiang, doctor \| 15101016416 \| 15101016416@126.com Principal Investigator: Tong Xianlin, professor Recruiting
Baoding Hospital of TCM	Baoding, Hebei, China Contact: Li Liping \| lilipingm@163.com Principal Investigator: Li Liping, professor Recruiting
Affiliated Hospital of Changchun University of TCM	Changchun, Jilin, China Contact: Piao Chunli, professor \| piaochunli981027@yahoo.com.cn Principal Investigator: Piao Chunli, professor Recruiting
Qinghai Provence Hospital of TCM	Xining, Qinghai, China Contact: Pu Weirong \| puweirong123@163.com Principal Investigator: Ba Zhuoma, professor Recruiting
Tianjin Dagang Hospital	Dagang, Tianjin, China Contact: Jin Chuan \| 58023442@qq.com Principal Investigator: Guo Hailong Recruiting
Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital	Tianjin, Tianjin, China Contact: Wu Shentao, professor \| 13752262891 \| wushentao@yahoo.com.cn Principal Investigator: Wu Shentao, professor Recruiting
Yichang City Yiling Hospital	Yichang, Yichang, China Contact: Yang Xingzhong \| clcy0401@163.com Principal Investigator: Yang Xingzhong Recruiting
Hangzhou Hospital of TCM	Hangzhou, Zhejiang, China Contact: Hong Yuzhi, professor \| hyzhcy@yahoo.cn Principal Investigator: Hong Yuzhi, professor Recruiting