Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules

Brief summary (registry, in English)

A multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of Prunella oral liquid in patients with benign thyroid nodules, which belongs to the post-marketing reevaluation clinical study. In this study, 234 subjects will be enrolled by competitive enrollment at several research centers across China. The main inclusion criteria are: ① Thyroid ultrasound examination found thyroid nodules, can be accompanied by goiter, and the nodules meet the following conditions: 1) There were dominant nodules in single or multiple nodules (the largest diameter of the second largest nodules was not more than 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules was ≥1cm and \< 3cm, 4) C-TIRADS 3\~4A nodules. ② Patients who met the puncture indication were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda II). ③ Levels of TSH, FT3 and FT4 were normal, and the antibody titers of TgAb and TPOAb were normal. Eligible subjects will be randomly assigned on a 1:1:2:2 scale to: Group A (placebo conventional dose group, 10 mL/times, 2 times/day), group B (placebo 2x dose group, 10ml/times, 2 times/day), group C (conventional dose group of Prunella oral liquid), group D (Prunella oral liquid 2x dose group). All subjects will receive the treatment for 9 months and follow up at 3rd, 6th, 9th and 12th month. The primary efficacy endpoint of this study was the rate of change in thyroid nodule volume from baseline at 9 months of treatment. The rate of change in thyroid nodule volume from baseline at 3 and 6 months of treatment was a secondary efficacy endpoint. Other secondary efficacy endpoints included maximum thyroid nodule diameter, number of thyroid nodules, proportion of patients with reduced thyroid nodule volume or ≥50% from baseline, thyroid volume, thyroid function (serum TSH, FT3, FT4, thyroid egg levels (Tg), thyroid antibody levels (TgAb, TPOAb), quality of life evaluation (SF-36), etc. Safety endpoints included incidence of AE/ serious adverse events (SAE), causality, and outcomes. Incidence of AE/SAE leading to discontinuation. Changes in safety laboratory test values from baseline.

What you commit to

• Study type: Interventional · Phase 4
• Planned participants: 234
• From 30 Jul 2024 to the primary completion date, 30 Jul 2025
• 22 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

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