Overweight , ObesityNCT07241533
Asiaticoside for Treating Overweight/Obesity
A study testing Asiaticoside tablets in people with Overweight , Obesity, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- Asiaticoside tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030
JINGJING JIANG, MD, PhD, 86-21-64041990, jiang.jingjing@zs-hospital.sh.cn
HUIJIE ZHANG, MD, PhD
About this study
Official title: 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.
- Conditions
- Overweight , Obesity
- Being tested
- Asiaticoside tablets
- Keywords
- obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asiaticoside tabletsDrug
Asiaticoside tablets 60mg tid for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants take Asiaticoside tablets 60mg tid for 12 weeks Receives: Drug: Asiaticoside tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 12
Secondary outcomes (11)
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.
Measured: Baseline to Week 12
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.
Measured: Baseline to Week 12
Change in waist circumference
Waist circumference will be measured using standardized anthropometric methods at baseline and Week 12 after taking Asiaticoside tablets.
Measured: From baseline to Week 12
Change in Blood Pressure
Systolic and diastolic blood pressure will be assessed at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Change in Lipid profile
Fasting lipid profile (TC, TG, LDL-C, HDL-C) will be assessed at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Change in HbA1c
Hemoglobin A1c will be assessed at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Change in Insulin Sensitivity (HOMA-IR)
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.
Measured: Baseline to Week 12
Change in Leptin Levels
Serum leptin levels will be measured at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
High-sensitivity C-reactive protein levels will be measured at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Change in Liver Fat Content
Liver fat content will be represented by the Controlled Attenuation Parameter (CAP) with FibroScan at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Change in Liver Stiffness
Liver stiffness will be represented by Liver Stiffness Measurement (LSM) with FibroScan at baseline and Week 12 after taking Asiaticoside tablets.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241533
- Sponsor's protocol ID
- B2025-710
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Efficacy Study of Asiaticoside for Treating Overweight/Obesity
- ClinicalTrials.gov ID
- NCT07241533
- Acronym / sponsor ID
- B2025-710
- Conditions
- Overweight , Obesity
- Keywords
- obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Asiaticoside tabletsParticipants take Asiaticoside tablets 60mg tid for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asiaticoside tabletsAsiaticoside tablets 60mg tid for 12 weeks | Drug | Intervention Arm |
Primary outcome
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.
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.
11 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline to Week 12
Change in Body Fat Percentage
Time frame: Baseline to Week 12
Change in waist circumference
Time frame: From baseline to Week 12
Change in Blood Pressure
Time frame: Baseline to Week 12
Change in Lipid profile
Time frame: Baseline to Week 12
Change in HbA1c
Time frame: Baseline to Week 12
Change in Insulin Sensitivity (HOMA-IR)
Time frame: Baseline to Week 12
Change in Leptin Levels
Time frame: Baseline to Week 12
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline to Week 12
Change in Liver Fat Content
Time frame: Baseline to Week 12
Change in Liver Stiffness
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asiaticoside tablets in people with Overweight , Obesity, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing JIANG, MD, PhD (86-021-64041990, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Metabolic Rate (time frame: Baseline to Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.