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Tests treatment safety and results for Thyroid Nodule
Official title Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
ClinicalTrials.gov ID: NCT06423235
What this study is testing
What is regular dose of JiRui® Prunella oral liquid?
regular dose of JiRui® Prunella oral liquid is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for thyroid nodule.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- Meet the diagnostic criteria of thyroid nodules in TCM;
You likely can't join if
- Exclude the patients with Deficiency of Yang syndrome, and the following two conditions can be diagnosed: Shortness of breath, abdominal pain and...
- 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...
- Patients who have taken prunella preparations or other similar Chinese medicines to treat the disease within the past 1 month; Patients using...
- Patients who have had or plan to take thyroid hormone, iodine compound, or antithyroid drug therapy during the study period;
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Shunde, Guangdong, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Qingdao, Shandong, China
- Weifang, Shandong, China
- Weihai, Shandong, China
- Shanghai, Shanghai Municipality, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Shunde, Guangdong, China; Wuhan, Hubei, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.