obesity
Conditions
Interventions
Intervention group1:Modified Xiao Xianxiong Decoction No.1
Intervention group2:Modified Xiao Xianxiong Decoction No.2
Intervention group3:Modified Xiao Xianxiong Decoction No.3
Control group1:Placebo Granules No.1
Control group2:Placebo Granules No.2
Control group3:Placebo Granules No.3
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–70 years; no gender restrictions; 2.Body Mass Index (BMI): = 28.0 kg/m²; 3.TCM Diagnosis: Meets the diagnostic criteria for Spleen-Stomach Damp-Heat syndrome as specified in the project expert consensus; 4.For the analysis group of obesity with Type 2 Diabetes Mellitus (T2DM): Subjects must meet the 1999 WHO diagnostic criteria for T2DM and the 2011 WHO supplementary diagnostic recommendations using glycated hemoglobin (HbA1c), with a confirmed diagnosis of T2DM for = 12 weeks; 5.For the analysis group of obesity with T2DM: HbA1c = 6.5% and = 10.0% at screening; 6.Fasting Blood Glucose (FBG): = 11.1 mmol/L (local laboratory) at screening; 7.Informed Consent: Subjects must be fully informed about the study and voluntarily sign the Informed Consent Form (ICF) prior to the trial.
Exclusion criteria
Exclusion criteria: 1.Pregnancy, Lactation, and Contraception: Female subjects who are pregnant or lactating, or subjects (including male subjects with partners) planning pregnancy during the study period; or subjects of childbearing potential who refuse to adopt protocol-specified contraceptive measures during the trial. 2.Diabetes Type: Subjects diagnosed with Type 1 Diabetes Mellitus (T1DM) or other specific types of diabetes (excluding Type 2 Diabetes Mellitus as per inclusion criteria). 3.Prior Weight Management Medication: Use of any weight management medication within 90 days prior to screening, or receipt of other treatments known to significantly affect body weight. This includes, but is not limited to, systemic glucocorticoid therapy (excluding topical or inhaled preparations), weight-loss teas/supplements, sodium valproate, citalopram, etc.Exception: Cumulative systemic glucocorticoid use $\le$ 2 weeks within 90 days prior to screening, provided the washout period exceeds 7 half-lives before the first screening day. 4.Bariatric Procedures: History of or planned surgical or other interventional procedures for weight loss during the study period.Exceptions: Liposuction and/or abdominoplasty (if performed >1 year prior to screening); gastric banding (if the band was removed >1 year prior to screening); intragastric balloon (if removed >1 year prior to screening); or duodenal-jejunal bypass sleeve (if the device was removed >1 year prior to screening). 5.Psychiatric History: History of major depressive disorder, severe psychiatric disorders (e.g.schizophrenia, bipolar disorder), or history of suicidal ideation or behavior. 6.Acute Pancreatitis: History of acute pancreatitis within 180 days prior to screening. 7.History of chronic pancreatitis or pancreatic surgery. 8.Abnormal Laboratory Values: Laboratory parameters at screening meeting any of the following criteria: (1) Alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN) or Aspartate aminotransferase (AST) > 3 x ULN; (2) Estimated Glomerular Filtration Rate (eGFR) 6 mIU/L or < 0.4 mIU/L. 9.Uncontrolled Hypertension: Uncontrolled or poorly controlled hypertension (Systolic Blood Pressure [SBP] = 160 mmHg and/or Diastolic Blood Pressure [DBP] = 100 mmHg at screening, confirmed by a repeat measurement). 10.Cardiovascular and Cerebrovascular Events: Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including but not limited to: decompensated heart failure (NYHA class III or IV), unstable angina, stroke or transient ischemic attack (TIA), myocardial infarction, severe arrhythmia, history of cardiac surgery or revascularization (including Coronary Artery Bypass Grafting [CABG] or Percutaneous Coronary Intervention [PCI]), or other cardiovascular/cerebrovascular conditions deemed unsuitable by the investigator. 11.Allergy: Known hypersensitivity to any component of the three Modified Xiaoxianxiong Decoction formulas, or subjects with active allergic diseases. 12.Participation in Other Trials: Participation in any other clinical trial within 3 months prior to screening (excluding subjects who failed screening or did not receive the investigational product for other reasons). 13.Non-Compliance: Inability to comply with the treatment regimen and the diet/exercise plan prescribed by the investigator. 14.Secondary Causes and GI Disorders: Presence of secondary causes of obesity (e.g., hy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight;Ultrasonic Attenuation Parameter(UAP);The ratio of T2DM remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| HOMA-IR;MRI-based Accurate Quantitative Detection of Hepatic Fat;Liver Stiffness Measurement(LSM);HOMAß;Time in range of 3.9-10.0mmol/L(TIR); HbA1c;fasting C-Peptide;fasting blood glucose(FBG);FINS;2h postprandial glucose;TCM Syndrome Score Scale;impact of weight on quality of life(IWQOL-Lite); | — |
Countries
China
Contacts
Public ContactDai Zhe
Zhongnan Hospital of Wuhan University
Outcome results
None listed