Overweight/obesity combined with hyperlipidemia (spleen asthenia and dampness accumulation syndrome)
Conditions
Interventions
Control group:Placebo
Trial Group:Fuling Gancao granules
Sponsors
Yunnan Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Above the age of 18 years and below the age of 70 years; male or female. (2) Body mass index (BMI) > 24.0 kg/m². (3) All subjects had stable weight (<5% fluctuation) in the 12 weeks preceding enrollment. (4) Meet the diagnostic criteria for hyperlipidemia. (5) Be diagnosed with the pattern of spleen asthenia and dampness accumulation syndrome according to Chinese Medicine theory. (6) Willing and able to adhere to the intervention protocol and maintain dietary records and followed-up regularly. (7) Participants agreed to take part in the study and signed the informed consent forms.
Exclusion criteria
Exclusion criteria: (1) Individuals with unintentional or passive weight loss due to illness or environmental factors. (2) Current or recent use of medications known to affect body weight (e.g. hormonal agents; hypoglycemic agents; weight-loss medications; antihistamines psychotropic drugs; beta-blockers oral contraceptives). (3) Vulnerable populations including individuals with mental illness; cognitive impairment; critical illness; or those who are pregnant or postpartum. (4) Patients with severe primary diseases (e.g. malignant tumors liver cirrhosis); secondary cardiovascular/cerebrovascular events (e.g. coronary heart disease stroke); psychiatric disorders or infectious diseases (including localized infections or systemic infections). (5) Failure to meet diagnostic criteria for spleen asthenia and dampness accumulation syndrome according to Chinese Medicine theory. (6) Deemed unsuitable for study participation by the investigators clinical judgment. (7) Poor compliance and can not finish the follow-up. (8) Concurrent enrollment in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores of Chinese Medicine syndromes;Weight;Lipid profile (seven items); | — |
Secondary
| Measure | Time frame |
|---|---|
| Protein (Proteomics);Waist circumference;Fasting blood glucose;Waist-to-hip ratio;Glycated hemoglobin (HbA1c);Hip circumference;Fasting insulin;Height;Insulin resistance index; | — |
Countries
China
Contacts
Public ContactJie Yu
Yunnan University of Chinese Medicine
Outcome results
None listed