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

January 5, 2026 updated by: zhengchuanming, Zhejiang Provincial People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Intervention + Xiaojin Pill
Participants receive lifestyle intervention combined with oral Xiaojin Pill for the management of thyroid nodules.
Drug: Xiaojin Pill
Xiaojin Pill is a traditional Chinese patent medicine administered orally at a dose of 3 g twice daily for 12 weeks.
Other Names:
  • Xiaojin Wan
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.
Experimental: Lifestyle Intervention + Neixiao Luoli Pill
Participants receive lifestyle intervention combined with oral Neixiao Luoli Pill for the management of thyroid nodules.
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.
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.
Other Names:
  • Neixiao Luoli Wan
Active Comparator: Lifestyle Intervention Alone
Participants receive lifestyle intervention alone without study medication.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage Change in Thyroid Nodule Volume
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Thyroid Nodule-Related Symptom Score Assessed by Visual Analog Scale (VAS)
Time Frame: Baseline and Week 12
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.
Baseline and Week 12
Change in Number of Thyroid Nodules
Time Frame: Baseline and Week 12
Baseline and Week 12
Change in Thyroid Nodule Ultrasound Characteristics Assessed by Standardized Ultrasound Examination
Time Frame: Baseline and Week 12
Thyroid nodule ultrasound characteristics include nodule shape, margin, echogenicity, calcification, and intranodular vascularity, assessed using standardized thyroid ultrasound examination.
Baseline and Week 12
Change in Thyroid Function Tests (Serum TSH, FT3, and FT4)
Time Frame: Baseline and Week 12
Thyroid function is assessed by measuring serum levels of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4).
Baseline and Week 12
Number of Participants with Adverse Events
Time Frame: Baseline through Week 12
Adverse events are recorded throughout the study period and include all unfavorable medical occurrences, regardless of their relationship to the study interventions.
Baseline through Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial People's Hospital

Investigators

  • Principal Investigator: Chuanming Zheng, Zhejiang Provincial People's Hospital
  • Study Chair: Yuqun Zeng, zhejiang provincial People's Hospitial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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