Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
NCT ID: NCT06423235
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
426 participants
INTERVENTIONAL
2024-07-30
2028-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo regular dose group
regular dose of placebo
Take 10ml twice a day
placebo 2x regular dose group
2x regular dose of placebo
Take 20ml twice a day
regular dose group of Prunella oral liquid group
regular dose of JiRui® Prunella oral liquid
Take 10ml twice a day
2x regular dose group of Prunella oral liquid group
2x regular dose of JiRui® Prunella oral liquid
Take 20ml twice a day
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Xintian Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Yuqing Li
Role: primary
Role: primary
Role: primary
Jie Zhu
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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XK-22-A-002-YJ-002
Identifier Type: -
Identifier Source: org_study_id
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