Starting soon
Phase 4
Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules
Condition(s) studied
Thyroid Nodules
Investigational drug(s) / intervention(s)
Xiaojin PillNeixiao Luoli PillLifestyle Intervention
Xiaojin Pill: Xiaojin Pill is a traditional Chinese patent medicine administered orally at a dose of 3 g twice daily for 12 weeks.
Neixiao Luoli Pill: Neixiao Luoli Pill is a traditional Chinese patent medicine administered orally at a dose of 9 g twice daily for 12 weeks.
Lifestyle Intervention: Lifestyle intervention includes stress management, emotional regulation, healthy diet, balanced iodine intake, avoidance of smoking and alcohol, adequate rest, and reduction of radiation exposure.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Percentage Change in Thyroid Nodule Volume — Baseline and Week 12
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Zhejiang Provincial People's Hospital |
Hangzhou |
Zhejiang |
|
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