Can a plant extract reduce thyroid nodules? new study seeks answers
NCT ID NCT06423235
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether Prunella oral liquid, a herbal remedy, can safely shrink benign (non-cancerous) thyroid nodules. About 234 adults with solid nodules between 1 and 3 cm will take the liquid or a placebo for 9 months. Researchers will measure changes in nodule size and check for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 234 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 18 years old ≤65 years old; * Thyroid ultrasonography found thyroid nodules, may be accompanied by goiter, and the nodules meet the following conditions: 1) single nodules, or dominant nodules in multiple nodules (the largest diameter of the second largest nodules does not exceed 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules ≥1cm and \< 3cm, 4) C-TIRADS 3\~4A nodules; * Patients who met the puncture indications were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda Class II); * Serum TSH, free thyroid hormone (FT3, FT4) levels were normal, anti-thyroglobulin (TgAb) and anti-thyroid peroxidase (TPOAb) antibody titers were normal; * Meet the diagnostic criteria of thyroid nodules in TCM; * Sign the informed consent. Exclusion Criteria: * Exclude the patients with Deficiency of Yang syndrome, and the following two conditions can be diagnosed: Shortness of breath, abdominal pain and diarrhea, diarrhea with undigested food, Insufficiency with chills, exhaustion and lethargy, pale tongue and white fur, deep and weak pulse * Those who have reproductive needs during pregnancy, lactation and within the last 12 months; * Patients with high possibility of thyroid cancer indicated by ultrasonic signs and malignant confirmed by fine needle biopsy; * Patients who meet the indications for thyroid nodule surgery, such as local compression symptoms obviously related to the nodule, the tumor is located behind the sternum or in the mediastinum, or strongly require surgery due to appearance or ideological concerns affecting normal life; * Patients who have taken prunella preparations or other similar Chinese medicines to treat the disease within the past 1 month; Patients using glucocorticoids in the last 3 months; * Patients who have had or plan to take thyroid hormone, iodine compound, or antithyroid drug therapy during the study period; * Patients who have previously or plan to undergo ablation, neck radiation, surgery and other non-drug treatments during the study period; * Patients with parathyroid tumor (PTA), medullary thyroid cancer (MTC) or other malignant tumors, or patients with serious cardiovascular disease, liver and kidney disease, osteoporosis, or patients with a history of mental illness; * Patients with a family history of thyroid cancer or thyroid cancer syndrome; * Laboratory test index ALT, AST \> 1.5 times the upper limit of reference value or blood creatinine (Scr) \> the upper limit of reference value; * Persons who are known to be allergic to the investigational drug or its ingredients; * Other patients determined by the investigator to be unsuitable for participation in the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
22 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First People's Hospital of Yunnan Province
RECRUITINGKunming, Yunnan, China
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Hospital of Liaoning University of Chinese Medicine
RECRUITINGShenyang, Liaoning, China
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Jiangsu Province Hospital of Integrated Chinese and Western Medicine
RECRUITINGNanjing, Jiangsu, China
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People's Hospital of Guangdong Province
RECRUITINGGuangzhou, Guangdong, China
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People's Hospital of Liaoning Province
RECRUITINGShenyang, Liaoning, China
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Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, China
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Second Hospital of Army Military Medical University
RECRUITINGChongqing, Chongqing Municipality, China
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Shanghai 10th People's Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Shanghai First People's Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Shanghai Pudong Zhoupu Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Shenzhen Hospital of Peking University
RECRUITINGShenzhen, Guangdong, China
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Shunde Hospital of Southern Medical University
RECRUITINGShunde, Guangdong, China
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The First Hospital of China Medical University
RECRUITINGShenyang, Liaoning, 200032, China
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The First Hospital of Kunming Medical University
RECRUITINGKunming, Yunnan, China
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The First Hospital of Qingdao University
RECRUITINGQingdao, Shandong, China
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The Second Hospital of Dalian Medical University
RECRUITINGDalian, Liaoning, China
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Weifang People's Hospital
RECRUITINGWeifang, Shandong, China
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Weihai Hospital
RECRUITINGWeihai, Shandong, China
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Wuhan First Hospital
RECRUITINGWuhan, Hubei, China
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Xiamen Hospital of Traditional Chinese Medicine
RECRUITINGXiamen, Fujian, China
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Xuzhou Medical University Hospital
RECRUITINGXuzhou, Jiangsu, China
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Zhejiang Province Hospital of Integrated Chinese and Western Medicine
RECRUITINGHangzhou, Zhejiang, China
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