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NOT YET RECRUITING
NCT07340177
PHASE4

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

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

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.

Official title: An Open-label, Multicenter, Randomized Controlled Clinical Trial of Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-03

Completion Date

2027-06

Last Updated

2026-01-14

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China