Obesity
Conditions
Interventions
Treatment group:Administration: Jianpi Huashi Granules, one packet dissolved in boiling water, taken orally twice daily (half an hour after breakfast and dinner) for 24 weeks.
Control Group:Administration: placebo, one packet dissolved in boiling water, taken orally twice daily (half an hour after breakfast and dinner) for 24 weeks.
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years. 2. Body Mass Index (BMI) = 28 kg/m² and < 37.5 kg/m². 3. Meeting the diagnostic criteria for obesity with low metabolism and the pattern of spleen deficiency and phlegm-dampness. 4. Voluntarily participating in the trial and providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Women who are currently pregnant or lactating, or plan to become pregnant within the next 2 years. 2. Patients with acute or chronic viral hepatitis, tuberculosis, malignant tumors, hepatic dysfunction, or chronic kidney disease (specifically defined as: serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 3 times the upper limit of normal (ULN); serum creatinine = 1.5 times ULN). 3. Patients with severe cardiovascular or cerebrovascular diseases within the past 6 months (e.g., acute myocardial infarction, stroke). 4. Patients with diabetes mellitus: HbA1c = 7%, or currently using any hypoglycemic agents (Western or Chinese medicine). 5. Patients with hypertension: blood pressure = 140/90 mmHg after regular antihypertensive medication. 6. Patients with other chronic diseases, such as hyperthyroidism, hypothyroidism, or gastrointestinal diseases (e.g., peptic ulcer bleeding, diarrhea, constipation, gastroesophageal reflux disease, colitis, history of gastrointestinal surgery). 7. Patients with endocrine disease-induced secondary obesity (e.g., abnormal cortisol secretion). 8. Patients with a history of bariatric surgery, or planning to undergo bariatric surgery or liposuction for weight loss during the study period. 9. Patients using drugs that affect hormone levels (e.g., hydrocortisone, prednisone, dexamethasone). 10. Use of medications affecting body weight or hypoglycemic drugs within 3 months before screening, including but not limited to: antidepressants, herbal medicines, metformin, GLP-1 receptor agonists, SGLT-2 inhibitors, levothyroxine, etc. 11. Patients with uncontrolled psychiatric disorders or currently taking antidepressants/antiepileptic drugs. 12. Participation in other clinical trials within the past 4 weeks. 13. Subjects with a known allergy to any component of the Chinese herbal granule formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in body mass index (BMI) compared to baseline level.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight;Waist circumference;Hip circumference;Waist-to-hip ratio;Waist-to-height ratio;Body fat percentage;Fasting Blood Glucose;Glycated hemoglobin;Fasting Insulin;Homeostasis model assessment for insulin resistance;Total Cholesterol;Triglyceride;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;High-sensitivity C-reactive protein;Tongue diagnosis;Facial diagnosis;Traditional Chinese Medicine Syndrome Score;Health Status Scale;Quality of Life Scale;Serum O-Link proteomics (inflammatory factors);Serum energy metabolomics;Serum targeted lipidomics;Gut Microbiota Metagenomic Sequencing;Urine Metabolomics;Carotid Ultrasound;Urinalysis; | — |
Countries
China
Contacts
Public ContactHui Dong
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed