Asiaticoside for Treating Overweight/Obesity | NCT07241533

Studies
Asiaticoside for Treating Overweight/Obesity

NCT07241533

Sponsor

Shanghai Zhongshan Hospital

Status

Recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Overweight , Obesity

Interventions

Asiaticoside tablets

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Arm	Experimental	Participants take Asiaticoside tablets 60mg tid for 12 weeks	Drug: Asiaticoside tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Asiaticoside tablets	Drug	Asiaticoside tablets 60mg tid for 12 weeks	Intervention Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Baseline to Week 12
Change in Body Fat Percentage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Jingjing JIANG, MD, PhD	Contact	86-021-64041990		jiang.jingjing@zs-hospital.sh.cn

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital, Fudan University	Recruiting	Shanghai	Shanghai Municipality	200030	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD that underlie results in a publication

Types

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).

URL

Not provided

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D050177	Overweight
D009765	Obesity