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NCT Number: NCT07241533

Asiaticoside for Treating Overweight/Obesity

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.

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Key information

Conditions

Overweight , Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

HUIJIE ZHANG, MD, PhD

PRINCIPAL_INVESTIGATOR

JINGJING JIANG, MD, PhD

CONTACT

[email protected]

86-21-64041990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Asiaticoside tablets

Drug

Asiaticoside tablets 60mg tid for 12 weeks

Primary outcomes

  1. Change in Metabolic Rate

    Time frame: 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.

  2. Change in Body Weight

    Time frame: Baseline to Week 12

    Body weight will be measured using a calibrated digital scale at baseline and Week 12 after taking Asiaticoside tablets.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: 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.

  2. Change in Body Fat Percentage

    Time frame: 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.

  3. Change in waist circumference

    Time frame: From baseline to Week 12

    Waist circumference will be measured using standardized anthropometric methods at baseline and Week 12 after taking Asiaticoside tablets.

  4. Change in Blood Pressure

    Time frame: Baseline to Week 12

    Systolic and diastolic blood pressure will be assessed at baseline and Week 12 after taking Asiaticoside tablets.

  5. Change in Lipid profile

    Time frame: 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.

  6. Change in HbA1c

    Time frame: Baseline to Week 12

    Hemoglobin A1c will be assessed at baseline and Week 12 after taking Asiaticoside tablets.

  7. Change in Insulin Sensitivity (HOMA-IR)

    Time frame: 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.

  8. Change in Leptin Levels

    Time frame: Baseline to Week 12

    Serum leptin levels will be measured at baseline and Week 12 after taking Asiaticoside tablets.

  9. Change in High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Baseline to Week 12

    High-sensitivity C-reactive protein levels will be measured at baseline and Week 12 after taking Asiaticoside tablets.

  10. Change in Liver Fat Content

    Time frame: 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.

  11. Change in Liver Stiffness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing JIANG, MD, PhD

CONTACT

[email protected]

86-021-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

A Clinical Efficacy Study of Asiaticoside for Treating Overweight/Obesity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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