NCT07340177Not yet recruitingPhase 4
Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules
An Open-label, Multicenter, Randomized Controlled Clinical Trial of Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether Xiaojin Pill or Neixiao Luoli Pill can safely treat thyroid nodules in adults aged 18 to 65 years with benign or low-risk thyroid nodules. The main questions it aims to answer are: * Does treatment with Xiaojin Pill or Neixiao Luoli Pill lower the size of thyroid nodules compared with lifestyle intervention alone? * Do Xiaojin Pill or Neixiao Luoli Pill improve thyroid nodule-related symptoms and ultrasound findings while remaining safe to use? Researchers will compare lifestyle intervention plus Xiaojin Pill, lifestyle intervention plus Neixiao Luoli Pill, and lifestyle intervention alone to see if adding Xiaojin Pill or Neixiao Luoli Pill works better than lifestyle intervention by itself. Participants will: * Be randomly assigned to one of the three study groups; * Receive lifestyle intervention guidance throughout the study; * Take Xiaojin Pill, Neixiao Luoli Pill, or no study medicine for 12 weeks, depending on their group; * Attend follow-up visits that include thyroid ultrasound exams, blood tests to check thyroid function and safety, and symptom assessments.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 20 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Zhejiang Provincial People's Hospital
- NCT number
- NCT07340177
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 108
- From Mar 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Thyroid nodules confirmed as malignant or follicular neoplasms requiring surgical intervention, or assessed by the investigator as unsuitable for active surveillance.
- History of severe cardiovascular, hepatic, renal, hematologic, psychiatric, autoimmune diseases, or other malignancies.
- Known allergy or hypersensitivity to Xiaojin Pill, Neixiao Luoli Pill, placebo components, or any ingredients of the study medications.
Other
- Presence of hyperthyroidism or hypothyroidism, defined as abnormal TSH, FT3, or FT4 levels.
- Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- Poor treatment compliance or inability to complete follow-up as judged by the investigator.
- Participation in another clinical trial during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.