Health Trials

Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules

ConditionThyroid Nodules
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhejiang Provincial People's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 65 years.

Diagnosed with single or multiple thyroid nodules confirmed by high-resolution ultrasound, with at least one measurable nodule.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xiaojin Pill

    Drug

    Xiaojin Pill is a traditional Chinese patent medicine administered orally at a dose of 3 g twice daily for 12 weeks.

  • Neixiao Luoli Pill

    Drug

    Neixiao Luoli Pill is a traditional Chinese patent medicine administered orally at a dose of 9 g twice daily for 12 weeks.

  • Lifestyle Intervention

    Behavioral

    Lifestyle intervention includes stress management, emotional regulation, healthy diet, balanced iodine intake, avoidance of smoking and alcohol, adequate rest, and reduction of radiation exposure.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Lifestyle Intervention + Xiaojin PillExperimental treatment 2 interventions
Group B: Lifestyle Intervention + Neixiao Luoli PillExperimental treatment 2 interventions
Group C: Lifestyle Intervention AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Change in Thyroid Nodule Volume

Time frame
Baseline and Week 12

Secondary outcomes

1

Change in Thyroid Nodule-Related Symptom Score Assessed by Visual Analog Scale (VAS)

Thyroid nodule-related symptoms include neck discomfort, swallowing difficulty, pressure sensation, and voice changes, assessed using a visual analog scale (VAS), with higher scores indicating more severe symptoms.

Time frame
Baseline and Week 12
2

Change in Number of Thyroid Nodules

Time frame
Baseline and Week 12
3

Change in Thyroid Nodule Ultrasound Characteristics Assessed by Standardized Ultrasound Examination

Thyroid nodule ultrasound characteristics include nodule shape, margin, echogenicity, calcification, and intranodular vascularity, assessed using standardized thyroid ultrasound examination.

Time frame
Baseline and Week 12
4

Change in Thyroid Function Tests (Serum TSH, FT3, and FT4)

Thyroid function is assessed by measuring serum levels of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4).

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: