NCT07340177

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to evaluate the clinical value of adding traditional Chinese medicine to standard lifestyle intervention for the management of benign or low-risk thyroid nodules. The trial adopts a randomized, parallel-group design conducted across multiple clinical centers. After screening and baseline assessments, eligible participants are allocated to one of three management strategies: lifestyle intervention alone or lifestyle intervention combined with one of two commonly used traditional Chinese patent medicines. The study is conducted in an open-label manner, reflecting real-world clinical practice. All participants receive standardized lifestyle guidance throughout the study period. Participants assigned to the intervention groups additionally receive oral herbal medication for a fixed treatment duration. Clinical assessments are performed at predefined time points to monitor structural changes of thyroid nodules, functional status of the thyroid gland, symptom evolution, and treatment safety. Thyroid ultrasound examinations are performed using standardized measurement procedures to ensure consistency across centers. Safety is continuously monitored through clinical evaluation and routine laboratory testing during the treatment and follow-up periods. The results of this study are expected to provide evidence regarding the role of traditional Chinese medicine as an adjunct to lifestyle management in patients with thyroid nodules under active surveillance.

Conditions

• Thyroid Nodules

Interventions

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

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: China