CompletedNot Applicable

Modified Huanglian Wendan Decoction for Metabolic Syndrome

China180 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Malondialdehyde Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Superoxide Dismutase Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Glutathione Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Glutathione Peroxidase Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Catalase Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Reactive Oxygen Species Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Trial details

NCT IDNCT07702669

SponsorFirst Affiliated Hospital of Heilongjiang Chinese Medicine University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Metabolic Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Malondialdehyde Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Superoxide Dismutase Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Glutathione Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Glutathione Peroxidase Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Catalase Level at 3 Months

Timeframe: Baseline and 3 months after treatment

Change From Baseline in Reactive Oxygen Species Level at 3 Months

Timeframe: Baseline and 3 months after treatment