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Ancient herbal formula may tame oxidative stress in metabolic syndrome

NCT ID NCT07702669

Disease control Sponsor: First Affiliated Hospital of Heilongjiang Chinese Medicine University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether adding a modified traditional Chinese herbal formula, Huanglian Wendan Decoction, to standard lifestyle and drug therapy can reduce oxidative stress in people with metabolic syndrome. About 180 adults will receive either standard care alone or standard care plus the herbal decoction for three months. Researchers will measure changes in blood markers of oxidative stress, along with weight, blood pressure, and blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a modified traditional Chinese herbal formula called Huanglian Wendan Decoction
What this could lead to
If successful, this could point toward an add-on herbal treatment that reduces oxidative stress and improves metabolic health in people with metabolic syndrome.
What could go wrong
This is a small, early-stage trial with only 180 participants, and the herbal formula is tested alongside standard drugs, so any added benefit may be modest or not generalizable.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Insulin Resistance metabolic syndrome X

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic syndrome

Contacts and locations

Locations

  • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150040, China

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