Obesity
Conditions
Interventions
placebo group:Placebo Combined with Non-Pharmacological Interventions in the XOWi Weight Management Program
XRXPY group:XRXPY Combined with Non-Pharmacological Interventions in the XOWi Weight Management Program
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 65 years old; (2) Meet the diagnostic criteria for simple obesity; (3) Conform to the assessment criteria of Dampness Syndrome and/or Heat Syndrome; (4) Weight loss of less than 5kg in the past three months; (5) Fully understand the study and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: (1) Secondary obesity due to conditions such as hypothyroidism hypercortisolism polycystic ovary syndrome (PCOS) etc.; (2) Glycated hemoglobin > 6.5% and/or fasting blood glucose = 7 mmol/L and/or 2-hour postprandial blood glucose = 11.1 mmol/L; (3) Use of weight-affecting medications such as glucocorticoids antiepileptic drugs or antipsychotic drugs in the past three months; (4) Suffering from chronic digestive system diseases that affect gut microbiota such as chronic nonspecific ulcerative colitis; (5) Use of antibiotics probiotic supplements nonsteroidal anti-inflammatory drugs (NSAIDs) proton pump inhibitors immunosuppressants or other medications affecting gut microbiota in the past three months or currently; (6) Currently taking medications that may affect treatment parameters (antidiabetic drugs such as metformin dipeptidyl peptidase-4 inhibitors glucagon-like peptide-1 receptor agonists acarbose sulfonylureas glinides thiazolidinediones sodium-glucose cotransporter-2 inhibitors insulin; lipid-lowering drugs such as statins fibrates ezetimibe); (7) Suffering from severe cardiovascular and cerebrovascular diseases hematologic disorders mental illnesses malignant tumors etc.; (8) Severe liver and kidney dysfunction with alanine aminotransferase or aspartate aminotransferase levels exceeding 2.5 times the normal value and glomerular filtration rate < 30 mL/min/1.73 m²; (9) Pregnant or breastfeeding women or women planning to become pregnant; (10) History of allergies to Scutellaria baicalensis Lithospermum erythrorhizon Atractylodes lancea or Pueraria lobata; (11) Conform to the assessment criteria of Yang Deficiency Syndrome; (12) Participation in other clinical studies and received investigational drugs or device treatments in the past three months; (13) Received other related weight loss treatments in the past six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with at least 5% body weight reduction;Percentage of body weight reduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life;Liver fat content;Glucose and lipid metabolic profile (fasting blood glucose, glycosylated hemoglobin, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol);Proportion of participants with at least 10% body weight reduction;Changes in body composition (waist circumference, waist-hip ratio, body fat percentage, body fat mass, trunk fat percentage, limb muscle mass percentage);Scores of TCM (Traditional Chinese Medicine) syndromes;Gut microbiota;Changes in Body Mass Index;Appetite;Insulin resistance (fasting serum insulin, fasting serum C-peptide, HOMA2-IR);Basal metabolic rate; | — |
Countries
China
Contacts
Public ContactTao Feng
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed