benign thyroid nodules Benign thyroid nodules Acupoint application Prunella vulgaris formula granules Clinical efficacy Safety Randomized controlled trial
Conditions
Interventions
Oral Prunella vulgaris formula granules (Manufacturer: Jiangsu Chenpai Pharmaceutical Group Co., Ltd., National Medicine Approval No.: Z20050519, Specification: 2g per bag) was administered, twice a d
once a day, 5 days of application per week and 2 days of rest, for 12 consecutive weeks. If obvious skin itching, erythema, blisters and other allergic reactions occurred during a
Active Comparator Drug,Active Comparator Other,Active Comparator Other
Drug Monotherapy,Patch Monotherapy,Combination
Sponsors
The Ninth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the criteria for benign thyroid nodules, and not meeting the surgical indications; (2) Aged 18-70 years old; (3) No drug, surgery, ablation or other treatments related to thyroid nodules received within 3 months before enrollment; (4) Voluntary participation and ability to cooperate with the completion of the whole treatment and follow-up, and signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Malignant or suspected malignant thyroid nodules with C-TIRADS grade >=4; (2) Patients with thyroid inflammatory diseases; (4) Complicated with primary diseases of severe heart, liver, kidney, hematopoietic system, etc., with liver and kidney functions exceeding 1.5 times the upper limit of normal value; (5) Pregnant or lactating women, or women planning pregnancy; (6) Skin damage at the application site, allergic constitution, or allergy to the drug components or application accessories in this study; (7) Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thyroid nodule volume reduction rate before and after treatment ultrasound,Total clinical effective rate after treatment Standards for Diagnosis and Efficacy of TCM Diseases combined with ultrasound indicators | — |
Secondary
| Measure | Time frame |
|---|---|
| Thyroid function and autoantibodies before and after treatment fasting venous blood,TCM syndrome score before and after treatment TCM syndrome scoring systems,Quality of life score before and after treatment SF-36 scale,Long-term recurrence rate 24 weeks followup nodule recurrence | — |
Countries
China
Contacts
Public ContactYanbing Guo
The Ninth Medical Center of PLA General Hospital
Outcome results
None listed