Asiaticoside for Treating Overweight/Obesity
ConditionOverweight , Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Asiaticoside tablets
DrugAsiaticoside tablets 60mg tid for 12 weeks
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Metabolic Rate
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.
Time frame
Baseline to Week 42
Change in Body Weight
Body weight will be measured using a calibrated digital scale at baseline and Week 12 after taking Asiaticoside tablets.
Time frame
Baseline to Week 12Secondary outcomes
1
Change in Body Mass Index (BMI)
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.
Time frame
Baseline to Week 122
Change in Body Fat Percentage
Body fat percentage will be evaluated using dual-energy X-ray absorptiometry (DEXA) at baseline and Week 12 after taking Asiaticoside tablets.
Time frame
Baseline to Week 123
Change in waist circumference
Waist circumference will be measured using standardized anthropometric methods at baseline and Week 12 after taking Asiaticoside tablets.
Time frame
From baseline to Week 124
Change in Blood Pressure
Systolic and diastolic blood pressure will be assessed at baseline and Week 12 after taking Asiaticoside tablets.
Time frame
Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov