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RECRUITING
NCT06423235
PHASE4

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

Sponsor: Xintian Pharmaceutical

View on ClinicalTrials.gov

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

DRUG

regular dose of JiRui® Prunella oral liquid

Take 10ml twice a day

DRUG

2x regular dose of JiRui® Prunella oral liquid

Take 20ml twice a day

DRUG

regular dose of placebo

Take 10ml twice a day

DRUG

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