An interventional study of Lifestyle Intervention and Standard Therapy in Metabolic Syndrome, sponsored by First Affiliated Hospital of Heilongjiang Chinese Medicine University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by First Affiliated Hospital of Heilongjiang Chinese Medicine University · Not applicable, Interventional, and Treatment
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 180 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →This is the only study on the registry with First Affiliated Hospital of Heilongjiang Chinese Medicine University as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive lifestyle intervention and standard therapy for 3 months. Lifestyle intervention includes health education, lifestyle modification, appropriate aerobic exercise, a low-salt and low-fat diet, reduced cholesterol intake, and increased dietary fiber intake. 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.
Behavioral: Lifestyle Intervention · Drug: Standard Therapy
Participants in this arm will receive Modified Huanglian Wendan Decoction in addition to the same lifestyle intervention and standard therapy used in the control group. Modified Huanglian Wendan Decoction will be prepared by the decoction room of The First Affiliated Hospital of Heilongjiang University of Chinese Medicine. The decoction will be administered orally at 150 mL twice daily, in the morning and evening, for 3 months.
Behavioral: Lifestyle Intervention · Drug: Standard Therapy · Drug: Modified Huanglian Wendan Decoction
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.
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.
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.
Change From Baseline in Malondialdehyde Level at 3 Months
Serum malondialdehyde level will be measured using enzyme-linked immunosorbent assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Superoxide Dismutase Level at 3 Months
Serum superoxide dismutase level will be measured using enzyme-linked immunosorbent assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Glutathione Level at 3 Months
Serum glutathione level will be measured using enzyme-linked immunosorbent assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Glutathione Peroxidase Level at 3 Months
Serum glutathione peroxidase level will be measured using enzyme-linked immunosorbent assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Catalase Level at 3 Months
Serum catalase level will be measured using enzyme-linked immunosorbent assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Reactive Oxygen Species Level at 3 Months
Serum reactive oxygen species level will be measured using enzyme-linked immunosorbent assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Waist Circumference at 3 Months
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.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Body Mass Index at 3 Months
Body mass index will be calculated as body weight in kilograms divided by height squared in meters.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Waist-to-Hip Ratio at 3 Months
Waist circumference and hip circumference will be measured, and waist-to-hip ratio will be calculated as waist circumference divided by hip circumference.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Waist-to-Height Ratio at 3 Months
Waist circumference and height will be measured, and waist-to-height ratio will be calculated as waist circumference divided by height.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Systolic Blood Pressure at 3 Months
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.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Diastolic Blood Pressure at 3 Months
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.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Total Cholesterol Level at 3 Months
Total cholesterol level will be measured by enzymatic method using a biochemical analyzer.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Triglyceride Level at 3 Months
Triglyceride level will be measured by enzymatic method using a biochemical analyzer.
Time frame: Baseline and 3 months after treatment
Change From Baseline in High-Density Lipoprotein Cholesterol Level at 3 Months
High-density lipoprotein cholesterol level will be measured using the ultracentrifugation method.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Low-Density Lipoprotein Cholesterol Level at 3 Months
Low-density lipoprotein cholesterol level will be measured using the ultracentrifugation method.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Fasting Insulin Level at 3 Months
Fasting insulin level will be measured using radioimmunoassay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Fasting Plasma Glucose Level at 3 Months
Fasting plasma glucose level will be measured by enzymatic method using a biochemical analyzer.
Time frame: Baseline and 3 months after treatment
Change From Baseline in 2-Hour Postprandial Glucose Level at 3 Months
Two-hour postprandial glucose level will be measured by enzymatic method using a biochemical analyzer.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Glycated Hemoglobin Level at 3 Months
Glycated hemoglobin level will be measured using latex immunoagglutination assay.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance at 3 Months
Homeostasis model assessment of insulin resistance will be calculated using the formula: fasting insulin multiplied by fasting plasma glucose divided by 22.5.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Triglyceride-Glucose Index at 3 Months
The triglyceride-glucose index will be calculated using the formula: natural logarithm of triglycerides multiplied by plasma glucose divided by 2.
Time frame: Baseline and 3 months after treatment
Change From Baseline in Triglyceride to High-Density Lipoprotein Cholesterol Ratio at 3 Months
The triglyceride to high-density lipoprotein cholesterol ratio will be calculated based on triglyceride and high-density lipoprotein cholesterol levels.
Time frame: Baseline and 3 months after treatment
Plan to share: No — Individual participant data will not be shared publicly because the study data contain personal health information, laboratory test results, treatment information, and oxidative stress-related outcomes from patients with metabolic syndrome. All study data will be de-identified and managed by the research team in accordance with the approved protocol, informed consent, ethical approval, and institutional data protection requirements.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.