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Prunella oral liquid for treating benign thyroid nodules

Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study

Phase 4 Interventional Xintian Pharmaceutical · NCT06423235

This trial will try two doses of Prunella oral liquid versus placebo to see if it is safe and can shrink benign thyroid nodules in adults.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment234 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorXintian Pharmaceutical Industry-sponsored
Drugs / interventionsradiation
Locations22 sites (Chongqing, Chongqing Municipality and 21 other locations)
Trial IDNCT06423235 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial enrolling 234 adults at several hospitals in China to test JiRui® Prunella oral liquid for benign thyroid nodules. Participants with solid nodules 1–3 cm that are cytologically benign (Bethesda II) and have normal thyroid function and antibodies are randomized to standard dose Prunella, double dose Prunella, standard-dose placebo, or double-dose placebo. Nodule size and safety outcomes will be compared between groups over the treatment period. The study is a post-marketing reevaluation designed to provide additional evidence on effectiveness and tolerability in routine clinical practice.

Who should consider this trial

Good fit: Adults 18–65 with solid, cytologically benign (Bethesda II) thyroid nodules between 1 and 3 cm, C-TIRADS 3–4A, normal TSH/FT3/FT4 and normal thyroid antibody levels who meet the trial's TCM criteria are ideal candidates.

Not a fit: Patients with suspected or confirmed malignant nodules, nodules outside the 1–3 cm range, predominantly cystic nodules, abnormal thyroid function or antibody levels, or those meeting the exclusion TCM syndromes are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this could offer a non-surgical medical option to reduce the size of some benign thyroid nodules and avoid more invasive treatments.

How similar studies have performed: Prior studies of Prunella and other herbal treatments for thyroid nodules are limited and mixed, so this post-marketing trial addresses an area with inconclusive evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 18 years old ≤65 years old;
* Thyroid ultrasonography found thyroid nodules, may be accompanied by goiter, and the nodules meet the following conditions: 1) single nodules, or dominant nodules in multiple nodules (the largest diameter of the second largest nodules does not exceed 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules ≥1cm and \< 3cm, 4) C-TIRADS 3\~4A nodules;
* Patients who met the puncture indications were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda Class II);
* Serum TSH, free thyroid hormone (FT3, FT4) levels were normal, anti-thyroglobulin (TgAb) and anti-thyroid peroxidase (TPOAb) antibody titers were normal;
* Meet the diagnostic criteria of thyroid nodules in TCM;
* Sign the informed consent.

Exclusion Criteria:

* Exclude the patients with Deficiency of Yang syndrome, and the following two conditions can be diagnosed: Shortness of breath, abdominal pain and diarrhea, diarrhea with undigested food, Insufficiency with chills, exhaustion and lethargy, pale tongue and white fur, deep and weak pulse
* Those who have reproductive needs during pregnancy, lactation and within the last 12 months;
* Patients with high possibility of thyroid cancer indicated by ultrasonic signs and malignant confirmed by fine needle biopsy;
* Patients who meet the indications for thyroid nodule surgery, such as local compression symptoms obviously related to the nodule, the tumor is located behind the sternum or in the mediastinum, or strongly require surgery due to appearance or ideological concerns affecting normal life;
* Patients who have taken prunella preparations or other similar Chinese medicines to treat the disease within the past 1 month; Patients using glucocorticoids in the last 3 months;
* Patients who have had or plan to take thyroid hormone, iodine compound, or antithyroid drug therapy during the study period;
* Patients who have previously or plan to undergo ablation, neck radiation, surgery and other non-drug treatments during the study period;
* Patients with parathyroid tumor (PTA), medullary thyroid cancer (MTC) or other malignant tumors, or patients with serious cardiovascular disease, liver and kidney disease, osteoporosis, or patients with a history of mental illness;
* Patients with a family history of thyroid cancer or thyroid cancer syndrome;
* Laboratory test index ALT, AST \> 1.5 times the upper limit of reference value or blood creatinine (Scr) \> the upper limit of reference value;
* Persons who are known to be allergic to the investigational drug or its ingredients;
* Other patients determined by the investigator to be unsuitable for participation in the study.

Where this trial is running

Chongqing, Chongqing Municipality and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thyroid Nodule
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.