Asiaticoside for Treating Overweight/Obesity

NCT07241533 | Recruiting

• 1 other identifier: B2025-710
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight , Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to Week 4

• Change in Body Weight

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

  Baseline to Week 12

Secondary Outcomes (11)

• Change in Body Mass Index (BMI)

  Baseline to Week 12

• Change in Body Fat Percentage

  Baseline to Week 12

• Change in waist circumference

  From baseline to Week 12

• Change in Blood Pressure

  Baseline to Week 12

• Change in Lipid profile

  Baseline to Week 12

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants take Asiaticoside tablets 60mg tid for 12 weeks

Drug: Asiaticoside tablets

Interventions

Asiaticoside tablets DRUG

Asiaticoside tablets 60mg tid for 12 weeks

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

asiaticoside

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jingjing JIANG, MD, PhD

CONTACT

86-021-64041990; jiang.jingjing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication.
• Access Criteria: IPD and supporting information will be avaible to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).

Locations

CN (1)