Study of Prunella Oral Liquid to Treat Benign Thyroid Nodules in Adults Aged 18 to 65 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 4 Trial

What this Trial Is About

Researchers are evaluating the efficacy and safety of Prunella oral liquid in adults with benign thyroid nodules. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to provide post-marketing reevaluation data on this treatment. Eligible participants have thyroid nodules confirmed benign by biopsy and normal thyroid hormone and antibody levels. The study includes 234 subjects recruited across multiple centers in China and focuses on changes in nodule volume and related health measures over time. Participants are randomly assigned to one of four groups receiving either a regular or double dose of Prunella oral liquid or a matching placebo at the same doses. Treatment lasts for 9 months, with follow-up visits scheduled at 3, 6, 9, and 12 months. Dosing is oral, twice daily, and the study includes monitoring for treatment effects and safety measures. During the study, participants undergo thyroid ultrasound examinations and blood tests to assess nodule size, thyroid function, antibody levels, and quality of life through questionnaires. Researchers track changes in nodule volume and diameter as primary and secondary outcomes, along with safety assessments such as adverse event monitoring and laboratory tests. The total participation duration spans up to 12 months, with thorough evaluations at specified intervals to understand treatment impact and safety.

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