Metabolic Syndrome
Conditions
Keywords
Modified Huanglian Wendan Decoction, Huanglian Wendan Decoction, Metabolic Syndrome, Oxidative Stress, Traditional Chinese Medicine, Randomized Controlled Trial, Insulin Resistance, Glucose Metabolism, Lipid Metabolism
Brief summary
This randomized controlled clinical study aims to evaluate the effect of Modified Huanglian Wendan Decoction on oxidative stress in patients with metabolic syndrome. A total of 180 patients with metabolic syndrome from The First Affiliated Hospital of Heilongjiang University of Chinese Medicine will be assigned to a control group or an observation group at a 1:1 ratio. Participants in both groups will receive lifestyle intervention and standard therapy, including antihypertensive, hypoglycemic, and lipid-lowering treatment. Participants in the observation group will additionally receive Modified Huanglian Wendan Decoction for 3 months. The study will compare changes in oxidative stress indicators, obesity-related parameters, blood pressure, glucose and lipid metabolism, and insulin resistance before and after treatment.
Detailed description
Metabolic syndrome is a cluster of metabolic abnormalities characterized by obesity, hypertension, dyslipidemia, impaired glucose metabolism, and insulin resistance. Oxidative stress is considered an important mechanism involved in the development and progression of metabolic syndrome. Traditional Chinese medicine may provide additional therapeutic benefits through multi-component and multi-target regulation. This study is a single-center, randomized controlled clinical study conducted at The First Affiliated Hospital of Heilongjiang University of Chinese Medicine. A total of 180 eligible patients with metabolic syndrome will be enrolled and randomly assigned to a control group or an observation group in a 1:1 ratio. Randomization will be performed using a random number table or randomization software by an independent staff member who is not involved in participant recruitment, treatment, or statistical analysis. All participants will receive lifestyle intervention, including health education, lifestyle modification, appropriate aerobic exercise, a low-salt and low-fat diet, reduced cholesterol intake, and increased dietary fiber intake. Participants in the control group will receive standard therapy, including valsartan capsules, metformin hydrochloride tablets, and atorvastatin calcium tablets. Participants in the observation group will receive Modified Huanglian Wendan Decoction in addition to the same lifestyle intervention and standard therapy used in the control group. The decoction will be administered orally twice daily for 3 months. Outcome assessments will be performed at baseline and after 3 months of treatment. The primary outcomes are oxidative stress indicators, including malondialdehyde, superoxide dismutase, glutathione, glutathione peroxidase, catalase, and reactive oxygen species. Secondary outcomes include waist circumference, body mass index, waist-to-hip ratio, waist-to-height ratio, systolic blood pressure, diastolic blood pressure, total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting insulin, fasting plasma glucose, 2-hour postprandial glucose, glycated hemoglobin, homeostasis model assessment of insulin resistance, triglyceride-glucose index, and triglyceride to high-density lipoprotein cholesterol ratio. The purpose of this study is to assess the clinical efficacy and safety of Modified Huanglian Wendan Decoction in patients with metabolic syndrome and to provide clinical evidence for traditional Chinese medicine in the management of metabolic syndrome and oxidative stress.
Interventions
BEHAVIORALLifestyle Intervention
Participants will receive lifestyle intervention, including basic health education, lifestyle modification, appropriate aerobic exercise for more than 30 minutes per day, a low-salt and low-fat diet, reduced cholesterol intake, and increased dietary fiber intake.
DRUGStandard Therapy
Standard therapy includes valsartan capsules 80 mg orally once daily, metformin hydrochloride tablets 0.5 g orally three times daily, and atorvastatin calcium tablets 10 mg orally once daily. Treatment will continue for 3 months.
DRUGModified Huanglian Wendan Decoction
Modified Huanglian Wendan Decoction consists of Coptidis Rhizoma 15 g, Pinelliae Rhizoma Praeparatum 10 g, Aurantii Fructus Immaturus 15 g, Bambusae Caulis in Taenias 10 g, Citri Reticulatae Pericarpium 15 g, Poria 15 g, Glycyrrhizae Radix et Rhizoma Praeparata cum Melle 10 g, Eucommiae Cortex 20 g, Achyranthis Bidentatae Radix 20 g, Puerariae Lobatae Radix 20 g, Salviae Miltiorrhizae Radix et Rhizoma 10 g, and Eupatorii Herba 15 g. The decoction will be prepared to 300 mL and administered orally at 150 mL twice daily, in the morning and evening, for 3 months.
Sponsors
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Blinding of participants and investigators is not feasible because the observation group will receive Modified Huanglian Wendan Decoction in addition to standard therapy, while the control group will receive standard therapy only. Standardized data collection procedures will be used to reduce potential bias.
Intervention model description
Participants will be randomly assigned to either the control group or the observation group in a 1:1 ratio. The control group will receive lifestyle intervention and standard therapy, while the observation group will receive Modified Huanglian Wendan Decoction in addition to lifestyle intervention and standard therapy. Outcomes will be assessed at baseline and after 3 months of treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 75 years. * Male or female patients. * Patients diagnosed with metabolic syndrome according to applicable clinical diagnostic criteria. * Patients treated in the outpatient department or inpatient ward of The First Affiliated Hospital of Heilongjiang University of Chinese Medicine. * Patients who are able to understand the study procedures and cooperate with treatment, examinations, and follow-up. * Patients who voluntarily participate in the study and sign the written informed consent form.
Exclusion criteria
* Patients with severe diseases of vital organs or systems, including severe cardiovascular, hepatic, renal, neurological, or hematopoietic diseases. * Patients with malignant tumors, autoimmune diseases, acute infectious diseases, or severe psychiatric disorders. * Pregnant or lactating women, or women planning pregnancy during the study period. * Patients with known allergy or intolerance to any study medication or herbal components used in this study. * Patients who have recently participated in another clinical study or are receiving other treatments that may affect the study outcomes. * Patients with poor compliance who cannot take the study medication regularly or complete follow-up. * Patients judged by the investigators to be unsuitable for participation in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Malondialdehyde Level at 3 Months | Baseline and 3 months after treatment | Serum malondialdehyde level will be measured using enzyme-linked immunosorbent assay. |
| Change From Baseline in Superoxide Dismutase Level at 3 Months | Baseline and 3 months after treatment | Serum superoxide dismutase level will be measured using enzyme-linked immunosorbent assay. |
| Change From Baseline in Glutathione Level at 3 Months | Baseline and 3 months after treatment | Serum glutathione level will be measured using enzyme-linked immunosorbent assay. |
| Change From Baseline in Glutathione Peroxidase Level at 3 Months | Baseline and 3 months after treatment | Serum glutathione peroxidase level will be measured using enzyme-linked immunosorbent assay. |
| Change From Baseline in Catalase Level at 3 Months | Baseline and 3 months after treatment | Serum catalase level will be measured using enzyme-linked immunosorbent assay. |
| Change From Baseline in Reactive Oxygen Species Level at 3 Months | Baseline and 3 months after treatment | Serum reactive oxygen species level will be measured using enzyme-linked immunosorbent assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Waist Circumference at 3 Months | Baseline and 3 months after treatment | Waist circumference will be measured in the fasting state in the morning at the minimum circumference between the lowest rib margin and the iliac crest. |
| Change From Baseline in Body Mass Index at 3 Months | Baseline and 3 months after treatment | Body mass index will be calculated as body weight in kilograms divided by height squared in meters. |
| Change From Baseline in Waist-to-Hip Ratio at 3 Months | Baseline and 3 months after treatment | Waist circumference and hip circumference will be measured, and waist-to-hip ratio will be calculated as waist circumference divided by hip circumference. |
| Change From Baseline in Waist-to-Height Ratio at 3 Months | Baseline and 3 months after treatment | Waist circumference and height will be measured, and waist-to-height ratio will be calculated as waist circumference divided by height. |
| Change From Baseline in Systolic Blood Pressure at 3 Months | Baseline and 3 months after treatment | Systolic blood pressure of the right upper arm will be measured before medication in the morning after at least 5 minutes of rest. The average value of three measurements will be recorded. |
| Change From Baseline in Diastolic Blood Pressure at 3 Months | Baseline and 3 months after treatment | Diastolic blood pressure of the right upper arm will be measured before medication in the morning after at least 5 minutes of rest. The average value of three measurements will be recorded. |
| Change From Baseline in Total Cholesterol Level at 3 Months | Baseline and 3 months after treatment | Total cholesterol level will be measured by enzymatic method using a biochemical analyzer. |
| Change From Baseline in Triglyceride Level at 3 Months | Baseline and 3 months after treatment | Triglyceride level will be measured by enzymatic method using a biochemical analyzer. |
| Change From Baseline in High-Density Lipoprotein Cholesterol Level at 3 Months | Baseline and 3 months after treatment | High-density lipoprotein cholesterol level will be measured using the ultracentrifugation method. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol Level at 3 Months | Baseline and 3 months after treatment | Low-density lipoprotein cholesterol level will be measured using the ultracentrifugation method. |
| Change From Baseline in Fasting Insulin Level at 3 Months | Baseline and 3 months after treatment | Fasting insulin level will be measured using radioimmunoassay. |
| Change From Baseline in Fasting Plasma Glucose Level at 3 Months | Baseline and 3 months after treatment | Fasting plasma glucose level will be measured by enzymatic method using a biochemical analyzer. |
| Change From Baseline in 2-Hour Postprandial Glucose Level at 3 Months | Baseline and 3 months after treatment | Two-hour postprandial glucose level will be measured by enzymatic method using a biochemical analyzer. |
| Change From Baseline in Glycated Hemoglobin Level at 3 Months | Baseline and 3 months after treatment | Glycated hemoglobin level will be measured using latex immunoagglutination assay. |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance at 3 Months | Baseline and 3 months after treatment | Homeostasis model assessment of insulin resistance will be calculated using the formula: fasting insulin multiplied by fasting plasma glucose divided by 22.5. |
| Change From Baseline in Triglyceride-Glucose Index at 3 Months | Baseline and 3 months after treatment | The triglyceride-glucose index will be calculated using the formula: natural logarithm of triglycerides multiplied by plasma glucose divided by 2. |
| Change From Baseline in Triglyceride to High-Density Lipoprotein Cholesterol Ratio at 3 Months | Baseline and 3 months after treatment | The triglyceride to high-density lipoprotein cholesterol ratio will be calculated based on triglyceride and high-density lipoprotein cholesterol levels. |
Countries
China
Outcome results
None listed