Metabolic SyndromeNCT07702669
Modified Huanglian Wendan Decoction for Metabolic Syndrome
A study testing Lifestyle Intervention, Standard Therapy and Modified Huanglian Wendan Decoction in people with Metabolic Syndrome, run by First Affiliated Hospital of Heilongjiang Chinese Medicine University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Lifestyle Intervention, Standard Therapy and Modified Huanglian Wendan Decoction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Lifestyle Intervention, Standard Therapy, Modified Huanglian Wendan Decoction
- Keywords
- Modified Huanglian Wendan Decoction, Huanglian Wendan Decoction, Metabolic Syndrome, Oxidative Stress, Traditional Chinese Medicine, Randomized Controlled Trial, Insulin Resistance, Glucose Metabolism, Lipid Metabolism
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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 TherapyDrug
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 DecoctionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lifestyle Intervention; Drug: Standard Therapy; Drug: Modified Huanglian Wendan Decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Malondialdehyde Level at 3 Months
Serum malondialdehyde level will be measured using enzyme-linked immunosorbent assay.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after treatment
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after treatment
Change From Baseline in Fasting Insulin Level at 3 Months
Fasting insulin level will be measured using radioimmunoassay.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Oct 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Heilongjiang Chinese Medicine University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Liu, First Affiliated Hospital of Heilongjiang Chinese Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702669
- Sponsor's protocol ID
- HZYLLKY202300301
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Huanglian Wendan Decoction on Oxidative Stress in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07702669
- Acronym / sponsor ID
- HZYLLKY202300301
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Heilongjiang Chinese Medicine UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy Group | Active comparator | Behavioral: Lifestyle Intervention, Drug: Standard TherapyParticipants 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. |
| Modified Huanglian Wendan Decoction Group | Experimental | Behavioral: Lifestyle Intervention, Drug: Standard Therapy, Drug: Modified Huanglian Wendan DecoctionParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionParticipants 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. | Behavioural | Modified Huanglian Wendan Decoction Group, Standard Therapy Group |
| Standard TherapyStandard 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 Group, Standard Therapy Group |
| Modified Huanglian Wendan DecoctionModified 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. | Drug | Modified Huanglian Wendan Decoction Group |
Primary outcome
Change From Baseline in Malondialdehyde Level at 3 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 3 months after treatment
Serum reactive oxygen species level will be measured using enzyme-linked immunosorbent assay.
17 secondary outcomes
Change From Baseline in Waist Circumference at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Body Mass Index at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Waist-to-Hip Ratio at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Waist-to-Height Ratio at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Systolic Blood Pressure at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Diastolic Blood Pressure at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Total Cholesterol Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Triglyceride Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in High-Density Lipoprotein Cholesterol Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Low-Density Lipoprotein Cholesterol Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Fasting Insulin Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Fasting Plasma Glucose Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in 2-Hour Postprandial Glucose Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Glycated Hemoglobin Level at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Triglyceride-Glucose Index at 3 Months
Time frame: Baseline and 3 months after treatment
Change From Baseline in Triglyceride to High-Density Lipoprotein Cholesterol Ratio at 3 Months
Time frame: Baseline and 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention, Standard Therapy and Modified Huanglian Wendan Decoction in people with Metabolic Syndrome, run by First Affiliated Hospital of Heilongjiang Chinese Medicine University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Malondialdehyde Level at 3 Months (time frame: Baseline and 3 months after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.