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Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
Sponsor: Xintian Pharmaceutical
Summary
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.
Official title: Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2024-07-30
Completion Date
2028-07-30
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
regular dose of JiRui® Prunella oral liquid
Take 10ml twice a day
2x regular dose of JiRui® Prunella oral liquid
Take 20ml twice a day
regular dose of placebo
Take 10ml twice a day
2x regular dose of placebo
Take 20ml twice a day
Locations (22)
Second Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
People's Hospital of Guangdong Province
Guangzhou, Guangdong, China
Shenzhen Hospital of Peking University
Shenzhen, Guangdong, China
Shunde Hospital of Southern Medical University
Shunde, Guangdong, China
Wuhan First Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu, China
Xuzhou Medical University Hospital
Xuzhou, Jiangsu, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Hospital of Liaoning University of Chinese Medicine
Shenyang, Liaoning, China
People's Hospital of Liaoning Province
Shenyang, Liaoning, China
The First Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Weihai Hospital
Weihai, Shandong, China
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pudong Zhoupu Hospital
Shanghai, Shanghai Municipality, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The First Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Province Hospital of Integrated Chinese and Western Medicine
Hangzhou, Zhejiang, China