Thyroid nodule
Conditions
Interventions
Combined treatment group:Thermal ablation + Ningying Fang oral + Sanying Gao topical
Conventional treatment group:Thermal ablation
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old, gender unrestricted. (2) Meet the diagnostic criteria of both Western and Traditional Chinese Medicine and the syndrome differentiation standard of "Phlegm and Blood Stasis Mutual Aggregation Syndrome" as stipulated in "Section 4: Diagnostic Criteria" of this protocol. (3) Undergo ultrasound-guided percutaneous thermal ablation treatment, and the target nodules should meet the following conditions: solid or cystic-solid (solid component = 50%); maximum diameter greater than 2.0 cm; when multiple nodules are present, select 1-2 nodules that most require intervention as the target nodules. (4) Thyroid function status should be normal or have received stable-dose (for more than 2 months) levothyroxine sodium replacement therapy and remain stable recently. (5) Prospective cohort: Voluntary participation, understanding of the research procedures, and signing of the written informed consent form; retrospective cohort: Complete medical records (including baseline and 6-month postoperative key data).
Exclusion criteria
Exclusion criteria: (1) Absolute or relative contraindications to thermal ablation treatment exist. (2) The patient is in an uncontrolled hyperthyroidism period or in an active period of autoimmune thyroiditis with significant functional abnormalities before ablation. (3) There is a history of previous neck surgery or radiotherapy on the same side. (4) Severe heart, liver or kidney dysfunction or active malignant tumors are present. (5) Pregnant or lactating women or those planning to become pregnant during the study period. (6) Known allergy to any component of the traditional Chinese medicine (Ningying Formula or Sanying Ointment) in the study protocol. (7) Use of glucocorticoids, immunosuppressants or biologics within the last 3 months. (8) Presence of mental disorders or cognitive impairments that prevent cooperation in the assessment. (9) Participation in other interventional clinical trials that may affect the outcome of thyroid nodules during the same period. (10) Retrospective cohort: Incomplete medical records (lacking baseline or 6-month follow-up key data) or missing key variable records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nodule volume reduction rate at 6 months post-ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total clinical effective rate;Improvement rate of TCM syndrome score;Psychological state (standard scores of SAS and SDS) and quality of life;Laboratory indicators: TPOAb, TgAb, ratios and counts of Th1/Th2/Th17/Treg, and IL23/TGFß/IL10; | — |
Countries
China
Contacts
Public ContactChen Yi
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed