Asiaticoside for Treating Overweight/Obesity

December 17, 2025 updated by: Shanghai Zhongshan Hospital

A Clinical Efficacy Study of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • HUIJIE ZHANG, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants take Asiaticoside tablets 60mg tid for 12 weeks
Drug: Asiaticoside tablets
Asiaticoside tablets 60mg tid for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 4
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.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 12
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.
Baseline to Week 12
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.
From baseline to Week 12
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.
Baseline to Week 12
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.
Baseline to Week 12
Change in HbA1c
Time Frame: Baseline to Week 12
Hemoglobin A1c will be assessed at baseline and Week 12 after taking Asiaticoside tablets.
Baseline to Week 12
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.
Baseline to Week 12
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.
Baseline to Week 12
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.
Baseline to Week 12
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.
Baseline to Week 12
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.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2025-710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

After publication.

IPD Sharing Access Criteria

IPD and supporting information will be avaible to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight , Obesity

Clinical Trials on Asiaticoside tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe