Modified Huanglian Wendan Decoction for Metabolic Syndrome

Effect of Modified Huanglian Wendan Decoction on Oxidative Stress in Patients With Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Lifestyle Intervention; Drug: Standard Therapy; Drug: Modified Huanglian Wendan Decoction

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Therapy Group; 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; 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.; Drug: Standard 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.
Experimental: Modified Huanglian Wendan Decoction Group; 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; 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.; Drug: Standard 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.; Drug: Modified 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Malondialdehyde Level at 3 Months	Serum malondialdehyde level will be measured using enzyme-linked immunosorbent assay.	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.	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.	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.	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.	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.	Baseline and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and 3 months after treatment
Change From Baseline in Fasting Insulin Level at 3 Months	Fasting insulin level will be measured using radioimmunoassay.	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.	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.	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.	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.	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.	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.	Baseline and 3 months after treatment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Heilongjiang Chinese Medicine University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Insulin Resistance; Metabolic Syndrome; Randomized Controlled Trial; Oxidative Stress; Traditional Chinese Medicine; Glucose Metabolism; Lipid Metabolism; Modified Huanglian Wendan Decoction; Huanglian Wendan Decoction
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Insulin Resistance; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HZYLLKY202300301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No