Obesity
Conditions
Interventions
Treatment group:Drug intervention: Jianpi Qinghua Granules,1 bag (15g) per dose, twice daily. Lifestyle intervention:(1) During weeks 1 to 4 after enrollment, intensive lifestyle management is implem
Placebo group:Simulated Jianpi Qinghua Granules (containing 5% effective components of Jianpi Qinghua Granules), one sachet (15g) per dose, twice daily. Lifestyle intervention: (1) Intensive lifestyle
Sponsors
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age: between 18 and 65 years (inclusive); (2) BMI: =28 kg/m² and <37.5 kg/m²; (3) Meet the diagnostic criteria for obesity of the type with high metabolism, spleen deficiency, and blood stasis-heat pattern; (4) Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Females currently in pregnancy, lactation, or planning pregnancy within the next 2 years; (2) Acute or chronic viral hepatitis, tuberculosis, malignant tumors, severe liver dysfunction, or chronic kidney disease, specifically: serum alanine aminotransferase and/or aspartate aminotransferase = 3 times the upper limit of normal, serum creatinine = 1.5 times the upper limit of normal; (3) Severe cardiovascular diseases (acute myocardial infarction and cerebrovascular accidents) within the past 6 months; (4) Patients with diabetes: HbA1c = 7%, or currently using Chinese and Western hypoglycemic drugs; (5) Patients with hypertension: Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg despite regular medication; (6) Patients with other chronic diseases, such as hyperthyroidism, hypothyroidism, gastrointestinal diseases (e.g., digestive tract ulcer bleeding, gastroesophageal reflux, colitis, and history of gastrointestinal surgery, etc.); (7) Secondary obesity caused by endocrine diseases: e.g., abnormal cortisol secretion, etc.; (8) History of weight loss surgery, or plans to undergo weight loss surgery, liposuction, or other weight loss methods during the study; (9) Use of drugs affecting hormone levels (e.g., hydrocortisone, prednisone, and dexamethasone, etc.); (10) Use of weight-affecting drugs or antidiabetic drugs within the past 3 months prior to screening, including but not limited to: antidepressants, Chinese herbal medicine, metformin, GLP-1 receptor agonists, SGLT-2 inhibitors, and levothyroxine, etc.; (11) Currently suffering from uncontrolled mental disorders or taking antidepressant/antiepileptic drugs; (12) Participation in other clinical trials within the past 4 weeks; (13) Subjects with allergies to the components of Chinese herbal granules; (14) Other situations deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| waist;Fasting Blood Glucose;Total Cholesterol;High-sensitivity C-reactive protein;TCM syndrome score;SF-36 Health Survey;Carotid Ultrasound Examination (intima-media thickness, plaque count, and plaque size);Waist-Hip Ratio;Waist-to-Height Ratio;Body fat percentage;HbA1c;Fasting Insulin;Homeostatic Model Assessment of Insulin Resistance;Triglyceride;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Impact of Weight on Quality of Life - Lite Clinical Trials Version Assessment Scale; | — |
Countries
China
Contacts
Public ContactJi Hangyu
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Outcome results
None listed