High risk assessment of thyroid nodules and traditional Chinese medicine intervention combined with disease and syndrome
- Conditions
- Thyroid nodules
- Registration Number
- ITMCTR2024000005
- Lead Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medicine Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
standard constrain:
(1) Age 18-75 years old;
(2) In line with the ultrasound diagnosis of thyroid nodules, including solid, cystic-solid, cystic nodules, and inflammatory nodules, and the long diameter of thyroid nodules = 0.5 cm and < 5.0 cm;
(3)Less than 4 bilobular thyroid nodules;
(4) Fine needle aspiration biopsy (FNAB) cytopathology of high-risk nodules suggests non-malignant lesions;
(5) Meet the diagnostic criteria of TCM syndrome of gall disease with liver stagnation and spleen deficiency syndrome;
(6) Those who signed the informed consent.
(1) Those who have childbearing needs during pregnancy, lactation and within the past 12 months;
(2) Nodule with clustered or coarse calcification on the edge or inside of the nodule;
(3) Those who are allergic to traditional Chinese medicine or its components;
(4)Patients with serious primary diseases or mental illness such as liver, kidney and hematopoietic system;
(5) Patients who have been diagnosed with thyroid cancer or combined with other malignant tumors;
(6) Patients with obvious local compression symptoms of the thyroid gland, hoarseness, dysphagia, etc. who meet the indications for surgical treatment and need surgical treatment;
(7) Anyone who is judged by the investigator to be unsuitable to participate in this trial;
(8) Those who have other concomitant medication related to thyroid function and nodule treatment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sum of products of vertical diameters of nodules;
- Secondary Outcome Measures
Name Time Method Thyroid function;TCM syndrome score;Thyroid enlargement and lymph nodes;Pittsburgh Sleep Quality Score;