obesity
Conditions
Interventions
control group:Placebo Combined with lifestyle Interventions
intervention group:XRXPY Combined with lifestyle Interventions
Sponsors
Shanghai Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Aged 18–65 years. 2)Meet the diagnostic criteria for obesity, defined as a body mass index (BMI) =28 kg/m² according to the "Chinese Adult Overweight and Obesity Prevention and Control Guide". 3)Meet the diagnostic criteria for the pattern of dampness-heat encumbering the spleenas defined in the "Guidelines for Clinical Research of New Chinese Medicines" . 4)Have attempted weight reduction previously through methods such as dieting, exercise, or acupuncture. 5)Provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1)Body weight fluctuation >3% within the last three months. 2)Presence of secondary obesity due to conditions such as hypothyroidism, hypercortisolism, or polycystic ovary syndrome. 3)Coexistence of severe primary diseases, including cardiovascular or cerebrovascular diseases, severe hepatic or renal insufficiency, or hematologic diseases. 4)Individuals with communication disorders, severe mental disorders, or visual/hearing impairments. 5)Women who are pregnant or lactating. 6)Use of medications known to affect body weight (e.g., glucocorticoids, antiepileptics, antipsychotics) within the past three months. 7)Previous diagnosis of diabetes or impaired glucose tolerance. 8)Severe hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels exceeding 2.5 times the upper limit of normal) or renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73m²). 9)History of allergy to any known Chinese herbal medicine. 10)Participation in other clinical trials involving investigational drugs or devices within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with obesity achieving a =5% reduction;body weight;body mass index; | — |
Secondary
| Measure | Time frame |
|---|---|
| change of body weight;trunk fat mass percentage;body fat mass percentage;waist circumference;hip circumference;Serum Total Cholesterol? ;Serum Total Triglyceride;Serum High-Density Lipoprotein Cholesterol;Scores of TCM (Traditional Chinese Medicine) syndromes;height; | — |
Countries
China
Contacts
Public ContactTAO Feng
Shanghai Traditional Chinese Medicine Hospital
Outcome results
None listed