Trial Title:
Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
NCT ID:
NCT06423235
Condition:
Thyroid Nodule
Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
regular dose of JiRui® Prunella oral liquid
Description:
Take 10ml twice a day
Arm group label:
regular dose group of Prunella oral liquid group
Intervention type:
Drug
Intervention name:
2x regular dose of JiRui® Prunella oral liquid
Description:
Take 20ml twice a day
Arm group label:
2x regular dose group of Prunella oral liquid group
Intervention type:
Drug
Intervention name:
regular dose of placebo
Description:
Take 10ml twice a day
Arm group label:
placebo regular dose group
Intervention type:
Drug
Intervention name:
2x regular dose of placebo
Description:
Take 20ml twice a day
Arm group label:
placebo 2x regular dose group
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, 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years old ≤65 years old;
- Thyroid ultrasonography found thyroid nodules, may be accompanied by goiter, and the
nodules meet the following conditions: 1) single nodules, or dominant nodules in
multiple nodules (the largest diameter of the second largest nodules does not exceed
50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules
≥1cm and < 3cm, 4) C-TIRADS 3~4A nodules;
- Patients who met the puncture indications were confirmed by fine needle aspiration
biopsy (FNAB) as benign nodules (Bethesda Class II);
- Serum TSH, free thyroid hormone (FT3, FT4) levels were normal, anti-thyroglobulin
(TgAb) and anti-thyroid peroxidase (TPOAb) antibody titers were normal;
- Meet the diagnostic criteria of thyroid nodules in TCM;
- Sign the informed consent.
Exclusion Criteria:
- Exclude the patients with Deficiency of Yang syndrome, and the following two
conditions can be diagnosed: Shortness of breath, abdominal pain and diarrhea,
diarrhea with undigested food, Insufficiency with chills, exhaustion and lethargy,
pale tongue and white fur, deep and weak pulse
- Those who have reproductive needs during pregnancy, lactation and within the last 12
months;
- Patients with high possibility of thyroid cancer indicated by ultrasonic signs and
malignant confirmed by fine needle biopsy;
- Patients who meet the indications for thyroid nodule surgery, such as local
compression symptoms obviously related to the nodule, the tumor is located behind
the sternum or in the mediastinum, or strongly require surgery due to appearance or
ideological concerns affecting normal life;
- Patients who have taken prunella preparations or other similar Chinese medicines to
treat the disease within the past 1 month; Patients using glucocorticoids in the
last 3 months;
- Patients who have had or plan to take thyroid hormone, iodine compound, or
antithyroid drug therapy during the study period;
- Patients who have previously or plan to undergo ablation, neck radiation, surgery
and other non-drug treatments during the study period;
- Patients with parathyroid tumor (PTA), medullary thyroid cancer (MTC) or other
malignant tumors, or patients with serious cardiovascular disease, liver and kidney
disease, osteoporosis, or patients with a history of mental illness;
- Patients with a family history of thyroid cancer or thyroid cancer syndrome;
- Laboratory test index ALT, AST > 1.5 times the upper limit of reference value or
blood creatinine (Scr) > the upper limit of reference value;
- Persons who are known to be allergic to the investigational drug or its ingredients;
- Other patients determined by the investigator to be unsuitable for participation in
the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Hospital of Army Military Medical University
Address:
City:
Chongqing
Country:
China
Investigator:
Last name:
Hongting Zheng
Email:
Sub-Investigator
Facility:
Name:
Xiamen Hospital of Traditional Chinese Medicine
Address:
City:
Xiamen
Country:
China
Investigator:
Last name:
Tianchi Hu
Email:
Sub-Investigator
Facility:
Name:
People's Hospital of Guangdong Province
Address:
City:
Guangzhou
Country:
China
Contact:
Phone:
（020）83827812
Investigator:
Last name:
Haixia Guan
Email:
Sub-Investigator
Facility:
Name:
Shenzhen Hospital of Peking University
Address:
City:
Shenzhen
Country:
China
Investigator:
Last name:
Fan Zhang
Email:
Sub-Investigator
Facility:
Name:
Shunde Hospital of Southern Medical University
Address:
City:
Shunde
Country:
China
Contact:
Phone:
0757-22318000
Investigator:
Last name:
Jie Shen
Email:
Sub-Investigator
Facility:
Name:
Wuhan First Hospital
Address:
City:
Wuhan
Country:
China
Investigator:
Last name:
Mingsong Gao
Email:
Sub-Investigator
Facility:
Name:
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Address:
City:
Nanjing
Country:
China
Investigator:
Last name:
Chao Liu
Email:
Sub-Investigator
Facility:
Name:
Xuzhou Medical University Hospital
Address:
City:
Xuzhou
Country:
China
Investigator:
Last name:
Hongwei Lin
Email:
Sub-Investigator
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Country:
China
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
200032
Country:
China
Contact:
Last name:
Yuqing Li
Phone:
+86 15140139773
Investigator:
Last name:
Zhongyan Shan
Email:
Principal Investigator
Facility:
Name:
Hospital of Liaoning University of Chinese Medicine
Address:
City:
Shenyang
Country:
China
Contact:
Phone:
82961387
Investigator:
Last name:
Tianshu Gao
Email:
Sub-Investigator
Facility:
Name:
People's Hospital of Liaoning Province
Address:
City:
Shenyang
Country:
China
Contact:
Phone:
024-24016001
Investigator:
Last name:
Binhong Wen
Email:
Sub-Investigator
Facility:
Name:
The First Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Contact:
Last name:
Jie Zhu
Investigator:
Last name:
Yangang Wang
Email:
Principal Investigator
Facility:
Name:
Weifang People's Hospital
Address:
City:
Weifang
Country:
China
Contact:
Phone:
963360
Investigator:
Last name:
Haixia Liu
Email:
Sub-Investigator
Facility:
Name:
Weihai Hospital
Address:
City:
Weihai
Country:
China
Contact:
Phone:
0631-5287120
Investigator:
Last name:
Yachao Yang
Email:
Sub-Investigator
Facility:
Name:
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Contact:
Phone:
02163864050-510905
Investigator:
Last name:
Dongjie Shen
Email:
Sub-Investigator
Facility:
Name:
Shanghai 10th People's Hospital
Address:
City:
Shanghai
Country:
China
Investigator:
Last name:
Shen Qu
Email:
Sub-Investigator
Facility:
Name:
Shanghai First People's Hospital
Address:
City:
Shanghai
Country:
China
Investigator:
Last name:
Yongde Peng
Email:
Sub-Investigator
Facility:
Name:
Shanghai Pudong Zhoupu Hospital
Address:
City:
Shanghai
Country:
China
Investigator:
Last name:
Jin'an Zhang
Email:
Sub-Investigator
Facility:
Name:
First People's Hospital of Yunnan Province
Address:
City:
Kunming
Country:
China
Investigator:
Last name:
Heng Su
Email:
Sub-Investigator
Facility:
Name:
The First Hospital of Kunming Medical University
Address:
City:
Kunming
Country:
China
Contact:
Phone:
0871-65324888
Investigator:
Last name:
Yushan Xu
Email:
Sub-Investigator
Facility:
Name:
Zhejiang Province Hospital of Integrated Chinese and Western Medicine
Address:
City:
Hangzhou
Country:
China
Investigator:
Last name:
Xin Mu
Email:
Sub-Investigator
Start date:
July 30, 2024
Completion date:
July 30, 2028
Lead sponsor:
Agency:
Xintian Pharmaceutical
Agency class:
Industry
Source:
Xintian Pharmaceutical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06423235
