Modified Huanglian Wendan Decoction for Metabolic Syndrome

NCT07702669 | Completed

• 1 other identifier: HZYLLKY202300301
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Modified Huanglian Wendan Decoction; Huanglian Wendan Decoction; Metabolic Syndrome; Oxidative Stress; Traditional Chinese Medicine; Randomized Controlled Trial; Insulin Resistance; Glucose Metabolism; Lipid Metabolism

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (17)

• Change From Baseline in Waist Circumference at 3 Months

  Baseline and 3 months after treatment

• Change From Baseline in Body Mass Index at 3 Months

  Baseline and 3 months after treatment

• Change From Baseline in Waist-to-Hip Ratio at 3 Months

  Baseline and 3 months after treatment

• Change From Baseline in Waist-to-Height Ratio at 3 Months

  Baseline and 3 months after treatment

• Change From Baseline in Systolic Blood Pressure at 3 Months

  Baseline and 3 months after treatment

Study Arms (2)

Standard Therapy Group

ACTIVE COMPARATOR

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

Modified Huanglian Wendan Decoction Group

EXPERIMENTAL

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

Interventions

Lifestyle Intervention BEHAVIORAL

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.

Modified Huanglian Wendan Decoction Group; Standard Therapy Group

Standard Therapy DRUG

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 Group; Standard Therapy Group

Modified Huanglian Wendan Decoction DRUG

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.

Modified Huanglian Wendan Decoction Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Heilongjiang Chinese Medicine University: lead

Study Sites (1)

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: October 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)