Thyroid NodulesPhase 4NCT07340177
Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules
A Phase 4 study testing Xiaojin Pill, Neixiao Luoli Pill and Lifestyle Intervention in people with Thyroid Nodules, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Nodules
- What is being tested?
- Xiaojin Pill, Neixiao Luoli Pill and Lifestyle Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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.
Read the 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
- Being tested
- Xiaojin Pill, Neixiao Luoli Pill, Lifestyle Intervention
- Keywords
- Thyroid nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaojin PillDrug
Also called Xiaojin Wan
Xiaojin Pill is a traditional Chinese patent medicine administered orally at a dose of 3 g twice daily for 12 weeks.
Neixiao Luoli PillDrug
Also called Neixiao Luoli Wan
Neixiao Luoli Pill is a traditional Chinese patent medicine administered orally at a dose of 9 g twice daily for 12 weeks.
Lifestyle InterventionBehavioural
Lifestyle intervention includes stress management, emotional regulation, healthy diet, balanced iodine intake, avoidance of smoking and alcohol, adequate rest, and reduction of radiation exposure.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention + Xiaojin Pill | Experimental | Participants receive lifestyle intervention combined with oral Xiaojin Pill for the management of thyroid nodules. Receives: Drug: Xiaojin Pill; Behavioral: Lifestyle Intervention |
| Lifestyle Intervention + Neixiao Luoli Pill | Experimental | Participants receive lifestyle intervention combined with oral Neixiao Luoli Pill for the management of thyroid nodules. Receives: Drug: Neixiao Luoli Pill; Behavioral: Lifestyle Intervention |
| Lifestyle Intervention Alone | Active comparator | Participants receive lifestyle intervention alone without study medication. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Thyroid Nodule Volume
Measured: Baseline and Week 12
Secondary outcomes (5)
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.
Measured: Baseline and Week 12
Change in Number of Thyroid Nodules
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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).
Measured: Baseline and Week 12
Number of Participants with Adverse Events
Adverse events are recorded throughout the study period and include all unfavorable medical occurrences, regardless of their relationship to the study interventions.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhengchuanming, Zhejiang Provincial People's Hospital
- Investigators
- Chuanming Zheng, Principal investigator, Zhejiang Provincial People's HospitalYuqun Zeng, Study chair, zhejiang provincial People's Hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340177
- Sponsor's protocol ID
- KY2025175
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized Controlled Clinical Trial of Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT07340177
- Acronym / sponsor ID
- KY2025175
- Conditions
- Thyroid Nodules
- Keywords
- Thyroid nodule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention + Xiaojin Pill | Experimental | Drug: Xiaojin Pill, Behavioral: Lifestyle InterventionParticipants receive lifestyle intervention combined with oral Xiaojin Pill for the management of thyroid nodules. |
| Lifestyle Intervention + Neixiao Luoli Pill | Experimental | Drug: Neixiao Luoli Pill, Behavioral: Lifestyle InterventionParticipants receive lifestyle intervention combined with oral Neixiao Luoli Pill for the management of thyroid nodules. |
| Lifestyle Intervention Alone | Active comparator | Behavioral: Lifestyle InterventionParticipants receive lifestyle intervention alone without study medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaojin PillAlso: Xiaojin WanXiaojin Pill is a traditional Chinese patent medicine administered orally at a dose of 3 g twice daily for 12 weeks. | Drug | Lifestyle Intervention + Xiaojin Pill |
| Neixiao Luoli PillAlso: Neixiao Luoli WanNeixiao Luoli Pill is a traditional Chinese patent medicine administered orally at a dose of 9 g twice daily for 12 weeks. | Drug | Lifestyle Intervention + Neixiao Luoli Pill |
| Lifestyle InterventionLifestyle intervention includes stress management, emotional regulation, healthy diet, balanced iodine intake, avoidance of smoking and alcohol, adequate rest, and reduction of radiation exposure. | Behavioural | Lifestyle Intervention + Neixiao Luoli Pill, Lifestyle Intervention + Xiaojin Pill, Lifestyle Intervention Alone |
Primary outcome
Percentage Change in Thyroid Nodule Volume
Time frame: Baseline and Week 12
5 secondary outcomes
Change in Thyroid Nodule-Related Symptom Score Assessed by Visual Analog Scale (VAS)
Time frame: Baseline and Week 12
Change in Number of Thyroid Nodules
Time frame: Baseline and Week 12
Change in Thyroid Nodule Ultrasound Characteristics Assessed by Standardized Ultrasound Examination
Time frame: Baseline and Week 12
Change in Thyroid Function Tests (Serum TSH, FT3, and FT4)
Time frame: Baseline and Week 12
Number of Participants with Adverse Events
Time frame: Baseline through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuanming Zheng principal investigator
Zhejiang Provincial People's Hospital
Yuqun Zeng study chair
zhejiang provincial People's Hospitial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiaojin Pill, Neixiao Luoli Pill and Lifestyle Intervention in people with Thyroid Nodules, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqun Zeng (+86-15058153877, zengyuqun401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Thyroid Nodule Volume (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.