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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
234
Take 10ml twice a day
Take 20ml twice a day
Take 10ml twice a day
Take 20ml twice a day
Second Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGXiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
RECRUITINGPeople's Hospital of Guangdong Province
Guangzhou, Guangdong, China
RECRUITINGShenzhen Hospital of Peking University
Shenzhen, Guangdong, China
RECRUITINGShunde Hospital of Southern Medical University
Shunde, Guangdong, China
RECRUITINGWuhan First Hospital
Wuhan, Hubei, China
RECRUITINGJiangsu Province Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu, China
RECRUITINGXuzhou Medical University Hospital
Xuzhou, Jiangsu, China
RECRUITINGThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITING...and 12 more locations
Rate of change in thyroid nodule volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Rate of change in thyroid nodule volume from baseline at 3 months of treatment.
Time frame: 90 ± 7 days.
Rate of change in thyroid nodule volume from baseline at 6 months of treatment.
Time frame: 180 ± 10 days.
Rate of change in thyroid nodule volume from baseline at 12 months of treatment.
Time frame: 360 ± 14 days.
The change value of the maximum diameter of thyroid nodules from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
The change value of the maximum diameter of thyroid nodules from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
The change value of the maximum diameter of thyroid nodules from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
The change value of the maximum diameter of thyroid nodules from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Proportion of patients with reduced thyroid nodule volume from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
Proportion of patients with reduced thyroid nodule volume from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with reduced thyroid nodule volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with reduced thyroid nodule volume from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
The proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Changes in the number of thyroid nodules from baseline at the 3 months of treatment.
Time frame: 90 ± 7 days
Changes in the number of thyroid nodules from baseline at the 6 months of treatment.
Time frame: 180 ± 10 days
Changes in the number of thyroid nodules from baseline at the 9 months of treatment.
Time frame: 270 ± 14 days
Changes in the number of thyroid nodules from baseline at the 12 months of treatment.
Time frame: 360 ± 14 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 3 months of treatment.
Time frame: 90 ± 7 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 12 months of treatment.
Time frame: 360 ± 14 days
Rate of change in thyroid volume from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
Rate of change in thyroid volume from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
Rate of change in thyroid volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Rate of change in thyroid volume from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment.
Time frame: 90 ± 7 days
Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment.
Time frame: 180 ± 10 days
Changes in serum TSH, FT3 and FT4 from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Changes in serum TSH, FT3 and FT4 from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Changes in Tg, TgAb and TPOAb levels from baseline at the 6th month of treatment.
Time frame: 180 ± 10 days
Proportion of patients with normal thyroid function at 3 months of treatment.
Time frame: 90 ± 7 days
Proportion of patients with normal thyroid function at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with normal thyroid function at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with normal thyroid function at 12 months of treatment.
Time frame: 360 ± 14 days
Subjects' quality of life scores (SF-36) at 3 months of treatment.
Time frame: 90 ± 7 days
Subjects' quality of life scores (SF-36) at 6 months of treatment.
Time frame: 180 ± 10 days
Subjects' quality of life scores (SF-36) at 9 months of treatment.
Time frame: 270 ± 14 days
Subjects' quality of life scores (SF-36) at 12 months of treatment.
Time frame: 360 ± 14 days
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