Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT07241533
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asiaticoside for Treating Overweight/Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004446', 'term': 'asiaticoside'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Metabolic Rate', 'timeFrame': 'Baseline to Week 4', 'description': '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.'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Baseline to Week 12', 'description': 'Body weight will be measured using a calibrated digital scale at baseline and Week 12 after taking Asiaticoside tablets.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline to Week 12', 'description': '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.'}, {'measure': 'Change in Body Fat Percentage', 'timeFrame': 'Baseline to Week 12', 'description': 'Body fat percentage will be evaluated using dual-energy X-ray absorptiometry (DEXA) at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in waist circumference', 'timeFrame': 'From baseline to Week 12', 'description': 'Waist circumference will be measured using standardized anthropometric methods at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline to Week 12', 'description': 'Systolic and diastolic blood pressure will be assessed at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in Lipid profile', 'timeFrame': 'Baseline to Week 12', 'description': 'Fasting lipid profile (TC, TG, LDL-C, HDL-C) will be assessed at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline to Week 12', 'description': 'Hemoglobin A1c will be assessed at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in Insulin Sensitivity (HOMA-IR)', 'timeFrame': 'Baseline to Week 12', 'description': '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.'}, {'measure': 'Change in Leptin Levels', 'timeFrame': 'Baseline to Week 12', 'description': 'Serum leptin levels will be measured at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in High-Sensitivity C-Reactive Protein (hs-CRP)', 'timeFrame': 'Baseline to Week 12', 'description': 'High-sensitivity C-reactive protein levels will be measured at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in Liver Fat Content', 'timeFrame': 'Baseline to Week 12', 'description': 'Liver fat content will be represented by the Controlled Attenuation Parameter (CAP) with FibroScan at baseline and Week 12 after taking Asiaticoside tablets.'}, {'measure': 'Change in Liver Stiffness', 'timeFrame': 'Baseline to Week 12', 'description': 'Liver stiffness will be represented by Liver Stiffness Measurement (LSM) with FibroScan at baseline and Week 12 after taking Asiaticoside tablets.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity'], 'conditions': ['Overweight , Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years or older, male or female.\n* Overweight or obesity, defined as a body mass index (BMI) of 24.0-45.0 kg/m².\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other severe infectious or immunocompromising conditions.\n* 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).\n* Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months.\n* Severe gastrointestinal disorders, or a history of gastrointestinal surgery within the past year.\n* Secondary causes of obesity, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, acromegaly; or drug-induced obesity (e.g., antipsychotics, glucocorticoids).\n* Currently receiving other anti-obesity treatments, a previous history of bariatric surgery, or a \\>5% reduction in body weight within the past 3 months.\n* Current smoker or habitual smoker within the past 3 months.\n* type 1 or type 2 diabetes mellitus or currently taking hypoglycemic medications.\n* Pregnancy or planning pregnancy, or breastfeeding.\n* Unable to complete a 3-month follow-up due to health conditions or relocation.\n* Participation in any clinical study within the past 4 weeks.\n* Other conditions considered by investigators as unsuitable for participation."}, 'identificationModule': {'nctId': 'NCT07241533', 'briefTitle': 'Asiaticoside for Treating Overweight/Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Clinical Efficacy Study of Asiaticoside for Treating Overweight/Obesity', 'orgStudyIdInfo': {'id': 'B2025-710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Participants take Asiaticoside tablets 60mg tid for 12 weeks', 'interventionNames': ['Drug: Asiaticoside tablets']}], 'interventions': [{'name': 'Asiaticoside tablets', 'type': 'DRUG', 'description': 'Asiaticoside tablets 60mg tid for 12 weeks', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JINGJING JIANG, MD, PhD', 'role': 'CONTACT', 'email': 'jiang.jingjing@zs-hospital.sh.cn', 'phone': '86-21-64041990'}, {'name': 'HUIJIE ZHANG, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jingjing JIANG, MD, PhD', 'role': 'CONTACT', 'email': 'jiang.jingjing@zs-hospital.sh.cn', 'phone': '86-021-64041990'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication', 'accessCriteria': 'IPD and supporting information will be avaible to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}