Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
NCT ID: NCT01471275
Last Updated: 2011-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
450 participants
INTERVENTIONAL
2011-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Jiangtangtiaozhi decoction
Jiangtangtiaozhi decoction
15 grams each time, twice a day, with boiled water
metformin
Metformin
250 mg or 500mg three times a day
Interventions
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Metformin
250 mg or 500mg three times a day
Jiangtangtiaozhi decoction
15 grams each time, twice a day, with boiled water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
65 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Fengmei Lian
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Principal Investigators
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Xiaolin Tong
Role: STUDY_CHAIR
China academy of Chinese medical science
Locations
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Guang'anmen Hospital of China Academy ofChinese Medical Sciences
Beijing, Beijing Municipality, China
Baoding Hospital of TCM
Baoding, Hebei, China
Affiliated Hospital of Changchun University of TCM
Changchun, Jilin, China
Qinghai Provence Hospital of TCM
Xining, Qinghai, China
Tianjin Dagang Hospital
Dagang, Tianjin Municipality, China
Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital
Tianjin, Tianjin Municipality, China
Yichang City Yiling Hospital
Yichang, Yichang, China
Hangzhou Hospital of TCM
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhou Qiang, doctor
Role: primary
Li Liping
Role: primary
Piao Chunli, professor
Role: primary
Pu Weirong
Role: primary
Jin Chuan
Role: primary
Wu Shentao, professor
Role: primary
Yang Xingzhong
Role: primary
Hong Yuzhi, professor
Role: primary
References
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Yu X, Xu L, Zhou Q, Wu S, Tian J, Piao C, Guo H, Zhang J, Li L, Wu S, Guo M, Hong Y, Pu W, Zhao X, Liu Y, Pang B, Peng Z, Wang S, Lian F, Tong X. The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial. Int J Endocrinol. 2018 Apr 1;2018:9519231. doi: 10.1155/2018/9519231. eCollection 2018.
Other Identifiers
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368
Identifier Type: -
Identifier Source: org_study_id