Prunella oral liquid for treating benign thyroid nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Second Hospital of Army Military Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Xiamen Hospital of Traditional Chinese Medicine
  Xiamen, Fujian, China Recruiting
• People's Hospital of Guangdong Province
  Guangzhou, Guangdong, China Recruiting
• Shenzhen Hospital of Peking University
  Shenzhen, Guangdong, China Recruiting
• Shunde Hospital of Southern Medical University
  Shunde, Guangdong, China Recruiting
• Wuhan First Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Wenjing Ji
• Email: yx-jiwj@xtyyoa.com
• Phone: +86 18365572279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.