A Phase 4 interventional study of Xiaojin Pill and Neixiao Luoli Pill in Thyroid Nodules, sponsored by Zhejiang Provincial People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Zhejiang Provincial People's Hospital · Phase 4, Interventional, and Treatment
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:
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:
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 108 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Zhejiang Provincial People's Hospital is the lead sponsor of 62 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive lifestyle intervention combined with oral Xiaojin Pill for the management of thyroid nodules.
Drug: Xiaojin Pill · Behavioral: Lifestyle Intervention
Participants receive lifestyle intervention combined with oral Neixiao Luoli Pill for the management of thyroid nodules.
Drug: Neixiao Luoli Pill · Behavioral: Lifestyle Intervention
Participants receive lifestyle intervention alone without study medication.
Behavioral: Lifestyle Intervention
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
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 includes stress management, emotional regulation, healthy diet, balanced iodine intake, avoidance of smoking and alcohol, adequate rest, and reduction of radiation exposure.
Percentage Change in Thyroid Nodule Volume
Time frame: Baseline and Week 12
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.
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
Thyroid nodule ultrasound characteristics include nodule shape, margin, echogenicity, calcification, and intranodular vascularity, assessed using standardized thyroid ultrasound examination.
Time frame: 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).
Time frame: 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.
Time frame: Baseline through Week 12
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhejiang Provincial People's Hospital