NCT07340177

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

December 20, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

December 20, 2025

Last Update Submit

January 5, 2026

Conditions

Thyroid Nodules

Keywords

Thyroid nodule

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Thyroid Nodule Volume

    Baseline and Week 12

Secondary Outcomes (5)

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

    Baseline and Week 12

  • Change in Number of Thyroid Nodules

    Baseline and Week 12

  • Change in Thyroid Nodule Ultrasound Characteristics Assessed by Standardized Ultrasound Examination

    Baseline and Week 12

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

    Baseline and Week 12

  • Number of Participants with Adverse Events

    Baseline through Week 12

Study Arms (3)

Lifestyle Intervention + Xiaojin Pill

EXPERIMENTAL

Participants receive lifestyle intervention combined with oral Xiaojin Pill for the management of thyroid nodules.

Drug: Xiaojin PillBehavioral: Lifestyle Intervention

Lifestyle Intervention + Neixiao Luoli Pill

EXPERIMENTAL

Participants receive lifestyle intervention combined with oral Neixiao Luoli Pill for the management of thyroid nodules.

Drug: Neixiao Luoli PillBehavioral: Lifestyle Intervention

Lifestyle Intervention Alone

ACTIVE COMPARATOR

Participants receive lifestyle intervention alone without study medication.

Behavioral: Lifestyle Intervention

Interventions

Lifestyle InterventionBEHAVIORAL

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

Lifestyle Intervention + Neixiao Luoli PillLifestyle Intervention + Xiaojin PillLifestyle Intervention Alone
Xiaojin PillDRUG

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

Also known as: Xiaojin Wan
Lifestyle Intervention + Xiaojin Pill
Neixiao Luoli PillDRUG

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

Also known as: Neixiao Luoli Wan
Lifestyle Intervention + Neixiao Luoli Pill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Conditions

Thyroid Nodule

Interventions

xiaojin wan

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Chuanming Zheng

    Zhejiang Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

  • Yuqun Zeng

    zhejiang provincial People's Hospitial

    STUDY CHAIR

Central Study Contacts

Yuqun Zeng

CONTACT

+86-15058153877zengyuqun401@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2025

First Posted

January 14, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 14, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)