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

Launched by XINTIAN PHARMACEUTICAL · May 15, 2024

Keywords

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Gender

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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.