Herbal pills tested as possible treatment for thyroid nodules
NCT ID NCT07340177
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 4 trial tests whether two traditional Chinese medicines, Xiaojin Pill and Neixiao Luoli Pill, can safely reduce the size of benign or low-risk thyroid nodules. About 108 adults aged 18 to 65 will be randomly assigned to take one of the pills or receive only lifestyle advice for 12 weeks. The study will compare changes in nodule volume and symptoms using ultrasound and questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Xiaojin Pill and Neixiao Luoli Pill (traditional Chinese patent medicines)
- What this could lead to
- If effective, these pills could offer a non-surgical option to shrink benign thyroid nodules and ease related symptoms.
- What could go wrong
- This is a small, early-phase trial with only 108 people. The pills may not work better than lifestyle changes alone, and long-term safety is unknown.
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 108 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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: * Adults aged 18 to 65 years. * Diagnosed with single or multiple thyroid nodules confirmed by high-resolution ultrasound, with at least one measurable nodule. * Thyroid nodules meeting one of the following criteria: * ACR TI-RADS category 3 with a maximum nodule diameter ≥ 1.0 cm; or * ACR TI-RADS category 4 or 5 nodules evaluated by fine-needle aspiration and assessed as low-risk papillary thyroid carcinoma, suitable for active surveillance, with patient consent. * Normal thyroid function at baseline, defined as thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) within the reference range. * Traditional Chinese medicine (TCM) syndrome differentiation consistent with liver qi stagnation, blood stasis, or phlegm-dampness syndrome. * Willing and able to provide written informed consent. Exclusion Criteria: * Thyroid nodules confirmed as malignant or follicular neoplasms requiring surgical intervention, or assessed by the investigator as unsuitable for active surveillance. * Presence of hyperthyroidism or hypothyroidism, defined as abnormal TSH, FT3, or FT4 levels. * History of severe cardiovascular, hepatic, renal, hematologic, psychiatric, autoimmune diseases, or other malignancies. * Pregnant or breastfeeding women, or women planning pregnancy during the study period. * Known allergy or hypersensitivity to Xiaojin Pill, Neixiao Luoli Pill, placebo components, or any ingredients of the study medications. * Receipt of thyroid-related surgery, radiofrequency ablation, laser ablation, radioactive iodine therapy, or other treatments that may affect thyroid nodules within 3 months prior to enrollment. * Current use of medications known to affect thyroid function or thyroid nodules, such as amiodarone or lithium. * Poor treatment compliance or inability to complete follow-up as judged by the investigator. * Participation in another clinical trial during the study period.
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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
1 site. 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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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
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