研究单位：[1]Xintian Pharmaceutical[2]Second Hospital of Army Military Medical University,Chongqing,Chongqing,China[3]Xiamen Hospital of Traditional Chinese Medicine,Xiamen,Fujian,China[4]People's Hospital of Guangdong Province,Guangzhou,Guangdong,China[5]Shenzhen Hospital of Peking University,Shenzhen,Guangdong,China[6]Shunde Hospital of Southern Medical University,Shunde,Guangdong,China[7]Wuhan First Hospital,Wuhan,Hubei,China[8]Jiangsu Province Hospital of Integrated Chinese and Western Medicine,Nanjing,Jiangsu,China[9]Xuzhou Medical University Hospital,Xuzhou,Jiangsu,China[10]The Second Hospital of Dalian Medical University,Dalian,Liaoning,China[11]The First Hospital of China Medical University,Shenyang,Liaoning,China,200032[12]Hospital of Liaoning University of Chinese Medicine,Shenyang,Liaoning,China[13]People's Hospital of Liaoning Province,Shenyang,Liaoning,China[14]The First Hospital of Qingdao University,Qingdao,Shandong,China[15]Weifang People's Hospital,Weifang,Shandong,China[16]Weihai Hospital,Weihai,Shandong,China[17]Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China[18]Shanghai 10th People's Hospital,Shanghai,Shanghai,China[19]Shanghai First People's Hospital,Shanghai,Shanghai,China[20]Shanghai Pudong Zhoupu Hospital,Shanghai,Shanghai,China[21]First People's Hospital of Yunnan Province,Kunming,Yunnan,China[22]The First Hospital of Kunming Medical University,Kunming,Yunnan,China[23]Zhejiang Province Hospital of Integrated Chinese and Western Medicine,Hangzhou,Zhejiang,China
研究目的：
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, 426 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 6 months of treatment. The rate of change in thyroid nodule volume from baseline at 3 and 9 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.
