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Can a plant extract reduce thyroid nodules? new study seeks answers

NCT ID NCT06423235

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 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: * 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.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • First People's Hospital of Yunnan Province

    RECRUITING

    Kunming, Yunnan, China

  • Hospital of Liaoning University of Chinese Medicine

    RECRUITING

    Shenyang, Liaoning, China

  • Jiangsu Province Hospital of Integrated Chinese and Western Medicine

    RECRUITING

    Nanjing, Jiangsu, China

  • People's Hospital of Guangdong Province

    RECRUITING

    Guangzhou, Guangdong, China

  • People's Hospital of Liaoning Province

    RECRUITING

    Shenyang, Liaoning, China

  • Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Second Hospital of Army Military Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Shanghai 10th People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanghai First People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanghai Pudong Zhoupu Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shenzhen Hospital of Peking University

    RECRUITING

    Shenzhen, Guangdong, China

  • Shunde Hospital of Southern Medical University

    RECRUITING

    Shunde, Guangdong, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 200032, China

  • The First Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, China

  • The First Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, China

  • The Second Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, China

  • Weifang People's Hospital

    RECRUITING

    Weifang, Shandong, China

  • Weihai Hospital

    RECRUITING

    Weihai, Shandong, China

  • Wuhan First Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Xiamen Hospital of Traditional Chinese Medicine

    RECRUITING

    Xiamen, Fujian, China

  • Xuzhou Medical University Hospital

    RECRUITING

    Xuzhou, Jiangsu, China

  • Zhejiang Province Hospital of Integrated Chinese and Western Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

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