Condition: Thyroid Nodule · Sponsor: Xintian Pharmaceutical
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 …
This description comes directly from the study's public registry record.
Wenjing Ji · +86 18365572279 · yx-jiwj@xtyyoa.com
Biao Chen · +86 13915637727 · ht-cb@xtyyoa.com
Always discuss trial participation with your own doctor first.
| 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 |
| Jiangsu Province Hospital of Integrated Chinese and Western Medicine | Nanjing, Jiangsu, China | Recruiting |
| Xuzhou Medical University Hospital | Xuzhou, Jiangsu, China | Recruiting |
| The Second Hospital of Dalian Medical University | Dalian, Liaoning, China | Recruiting |
| The First Hospital of China Medical University | Shenyang, Liaoning, China | Recruiting |
| Hospital of Liaoning University of Chinese Medicine | Shenyang, Liaoning, China | Recruiting |
| People's Hospital of Liaoning Province | Shenyang, Liaoning, China | Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06423235