Overweight and Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients with a BMI of 24 kg/m² to 32.5 kg/m² who are diagnosed with the syndrome of spleen deficiency and damp-heat in Traditional Chinese Medicine. (2) Patients aged between 20 and 75 years old.
Exclusion criteria
Exclusion criteria: (1) Patients with glycated hemoglobin (HbA1c) > 9% who have been diagnosed with diabetes mellitus and are currently using medications for control. (2) Pregnant or breastfeeding women. (3) Patients with severe complications of the heart liver or kidneys or with abnormal liver or kidney function (e.g. liver enzymes more than 3 times the upper limit of normal estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73m²) or those with other severe primary diseases or psychiatric conditions. (4) Patients who are allergic to any of the medications in the treatment regimen or who are not suitable for this treatment plan. (5) Patients who have used traditional Chinese medicine or patent Chinese medicines within the past 3 months or who have participated in other drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of achieving a 15% weight reduction within 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) Syndrome Score;Hip circumference;Waist circumference;Health Status Questionnaire;Weight;Body Mass Index;Homeostatic Model Assessment of Insulin Resistance;Fasting blood glucose;Fasting insulin;Glycated hemoglobin;Total cholesterol;Triglycerides;High-density lipoprotein;Low-density lipoprotein; | — |
Countries
China
Contacts
Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital