Overweight , Obesity
Conditions
Keywords
obesity
Brief summary
Centella asiatica is a traditional herbal medicine widely used in China and Southeast Asia for treating various conditions. Preclinical studies have shown that madecassic acid glycosides, including asiaticoside and madecassoside, can significantly reduce body weight gain, adipose tissue mass, and serum triglyceride levels in high-fat diet-induced obese mice. These compounds also improve hepatic steatosis and insulin resistance. This exploratory, interventional study aims to evaluate the clinical efficacy of orally administered asiaticoside tablets in adults with overweight or obesity.
Interventions
DRUGAsiaticoside tablets
Asiaticoside tablets 60mg tid for 12 weeks
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older, male or female. * Overweight or obesity, defined as a body mass index (BMI) of 24.0-45.0 kg/m². * Able and willing to provide written informed consent.
Exclusion criteria
* Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other severe infectious or immunocompromising conditions. * Severe liver injury (AST or ALT \> 3 times the upper limit of normal) or severe renal dysfunction/end-stage renal disease (eGFR \< 30 mL/min/1.73 m²). * Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months. * Severe gastrointestinal disorders, or a history of gastrointestinal surgery within the past year. * Secondary causes of obesity, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, acromegaly; or drug-induced obesity (e.g., antipsychotics, glucocorticoids). * Currently receiving other anti-obesity treatments, a previous history of bariatric surgery, or a \>5% reduction in body weight within the past 3 months. * Current smoker or habitual smoker within the past 3 months. * type 1 or type 2 diabetes mellitus or currently taking hypoglycemic medications. * Pregnancy or planning pregnancy, or breastfeeding. * Unable to complete a 3-month follow-up due to health conditions or relocation. * Participation in any clinical study within the past 4 weeks. * Other conditions considered by investigators as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Metabolic Rate | Baseline to Week 4 | Metabolic rate will be assessed using indirect calorimetry in a metabolic chamber (whole-room indirect calorimetry) at baseline and Week 4 after taking Asiaticoside tablets. |
| Change in Body Weight | Baseline to Week 12 | Body weight will be measured using a calibrated digital scale at baseline and Week 12 after taking Asiaticoside tablets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat Percentage | Baseline to Week 12 | Body fat percentage will be evaluated using dual-energy X-ray absorptiometry (DEXA) at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in Blood Pressure | Baseline to Week 12 | Systolic and diastolic blood pressure will be assessed at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in Lipid profile | Baseline to Week 12 | Fasting lipid profile (TC, TG, LDL-C, HDL-C) will be assessed at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in HbA1c | Baseline to Week 12 | Hemoglobin A1c will be assessed at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in waist circumference | From baseline to Week 12 | Waist circumference will be measured using standardized anthropometric methods at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in Leptin Levels | Baseline to Week 12 | Serum leptin levels will be measured at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline to Week 12 | High-sensitivity C-reactive protein levels will be measured at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in Liver Fat Content | Baseline to Week 12 | Liver fat content will be represented by the Controlled Attenuation Parameter (CAP) with FibroScan at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in Liver Stiffness | Baseline to Week 12 | Liver stiffness will be represented by Liver Stiffness Measurement (LSM) with FibroScan at baseline and Week 12 after taking Asiaticoside tablets. |
| Change in Insulin Sensitivity (HOMA-IR) | Baseline to Week 12 | HOMA-IR will be calculated at baseline and Week 12 after taking Asiaticoside tablets. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5. |
| Change in Body Mass Index (BMI) | Baseline to Week 12 | Body mass index (BMI) will be calculated as weight (kg) divided by height squared (m²). This outcome assesses changes in BMI from baseline to Week 12. |
Countries
China
Contacts
Primary ContactJingjing JIANG, MD, PhD
Outcome results
None listed