Ancient herbal mix may shield blood vessels in diabetes

NCT ID NCT07775664

Running, but no longer taking on new participants.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a traditional Chinese herbal formula, Huangqi Gegen Decoction, can improve blood vessel function in adults with type 2 diabetes who are at very high risk for heart disease. Participants will take either the herbal granules or a placebo for 12 weeks, alongside their usual diabetes care. The main goal is to see if the herbs help blood vessels dilate better, which is a sign of improved cardiovascular health.

What this could mean

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

Active substance
Huangqi Gegen Decoction granules (a traditional Chinese herbal formula of Huangqi and Gegen)
What this could lead to
If effective, this herbal addition could offer a new way to protect blood vessels and reduce heart disease risk in people with type 2 diabetes.
What could go wrong
This is a small, early-stage trial, and results may not apply broadly. The herbal mix could also interact with other medications or cause side effects.

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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

90 people

The number who actually took part.

Started

Aug 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

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: * Aged 18 to 75 years. * Diagnosed with type 2 diabetes mellitus, with fasting plasma glucose \<9.0 mmol/L and glycated hemoglobin (HbA1c) \<8.5%, and receiving a stable glucose-lowering treatment regimen without adjustment during the previous 3 months. * Type 2 diabetes mellitus with target-organ damage or at least 3 additional cardiovascular risk factors. * Meets the diagnostic criteria for Qi-Yin deficiency syndrome in traditional Chinese medicine, including: (a) primary symptoms of dry mouth and thirst, palpitations, and shortness of breath; (b) secondary symptoms including spontaneous sweating, fatigue, chest tightness, chest discomfort or pain, heat sensation in the palms and soles, polyuria, or constipation; and (c) dark-red tongue and weak, thready pulse. The diagnosis requires at least 2 primary symptoms together with supporting secondary symptoms and tongue/pulse findings, and must be confirmed by at least 2 traditional Chinese medicine physicians at attending-physician level or above. * Voluntarily participates in the study and provides written informed consent. * Has received stable conventional treatment for at least 3 months before enrollment, with the treatment regimen consistent with relevant Chinese clinical guidelines for diabetes and chronic coronary syndromes. Exclusion Criteria: * Allergy to the traditional Chinese medicines used in the study or a history of multiple drug allergies. * History of severe arrhythmia, including recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response, or New York Heart Association (NYHA) functional class III-IV heart failure. * Abnormal thyroid function, including hyperthyroidism or hypothyroidism, defined as thyroid-stimulating hormone below the lower limit of normal or greater than 1.5 times the upper limit of normal. * History of malignant tumor within the previous 5 years. * Major surgery within the previous 3 months or planned major surgery during the study period. * Long-term or repeated use of systemic glucocorticoids within the previous 3 months. * Active infectious disease at screening or randomization, psychiatric illness, pregnancy or breastfeeding, or any other condition considered by the investigator to make participation inappropriate. * Current use of other medications that may significantly affect systemic immune function. * Acute infection or an active inflammatory condition, such as a respiratory tract infection or recent surgery. * Hematologic disorders that may affect immune or inflammatory markers, including chronic myeloid leukemia, idiopathic thrombocytopenic purpura, or aplastic anemia. * Current use of long-acting nitrates or other medications that may affect vasodilatory function. * Use of other traditional Chinese medicine preparations or dietary supplements with known anti-inflammatory or antioxidant effects, such as curcumin or coenzyme Q10, within 1 month before screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Putuo Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200062, China

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