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Clinical study for Yi-Qi Hua-Ju method combined with individualized diet management int the treatment of obesity

Not Applicable
Conditions
Obesity
Registration Number
ITMCTR2000003606
Lead Sponsor
Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Obesity diagnosis in accordance with Chinese guidelines for prevention and control of overweight and obesity in adults (Pilot version);
2. Traditional Chinese medicine belongs to the syndrome of spleen deficiency and phlegm dampness;
3. Aged 18-65 years old;
4. TG<=5mmol/L;
5. The subjects had no major organ dysfunction and normal liver, kidney and heart functions: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 ULN. Creatinine <=1.5 ULN;
6. Sign informed consent.

Exclusion Criteria

1. Systolic blood pressure > 160mmhg, or diastolic blood pressure > 100mmhg;
2. Patients with diabetes or those who have received hypoglycemic drugs;
3. Patients with myocardial infarction, heart failure or unstable angina pectoris;
4. Patients with history of stroke;
5. Pregnant or lactating women;
6. Patients with mental illness;
7. Tumor patients;
8. Patients who are allergic to the test drug or its components;
9. Patients who have received Chinese and Western medicine for weight loss within three months.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
BMI;
Secondary Outcome Measures
NameTimeMethod
glycosylated hemoglobin;CRP;blood lipids;IL-6;blood glucose;PAI-1;TNF-alpha;Insulin;t-PA;
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