Subacute thyroiditis
Conditions
Interventions
control group:prednisolone
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. Diagnosis of SAT and presenting with moderate to severe pain (sore > 7/10) or failing to respond to full doses of NSAIDs; 3. Provide informed consent before any study-specific procedures and not involved in another clinical study in the previous 3 months.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, intending to become pregnant during the study period, currently lactating women, or women of childbearing potential not using highly effective, medically approved methods of birth control; 2. Suspicion or diagnosis of acute suppurative thyroiditis, Graves disease, Hashimoto thyroiditis, or thyroid carcinoma; 3. Glucocorticoids allergy or intolerance (e.g. systemic allergic reaction, induced asthma, bleeding, ulcer and perforation of stomach or intestine); 4. Previous treatment with PSLs in the last 6 months before screening; 5. Adrenocortical hyperfunction, uncontrolled hypertension, or diabetes; 6. Patients with clinically apparent liver disease characterized by any of the following: (1) ALT or AST > 3x upper limit of normal confirmed on two consecutive measurements (by local laboratory) within 4 weeks before the screening period; (2) Impaired excretory (e.g. hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices; (3) Acute viral or active autoimmune, alcoholic, or other types of hepatitis; 7. Patients with moderate /severe renal impairment or end-stage renal disease (estimated glomerular filtration rate <= 60mL/min calculated by using the abbreviated equation developed by the Modification of Diet in Renal Disease study with modification for the Chinese population) at screening or within 4 weeks before screening (by local laboratory); 8. Congestive heart failure defined as New York Heart Association class iii or iv; 9. Significant cardiovascular history within the past 3 months before screening defined as myocardial infarction, coronary angioplasty or bypass graft(s),valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident; 10. History of mental illness; 11. History of corneal ulcer; 12. History of gastrointestinal disease including gastroenterostomy, enterectomy, Roemheld syndrome, severe hernia, and intestinal obstruction; 13. Postoperative patients with unhealing wound; 14. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years; 15. History of organ transplant or acquired immunodeficiency syndrome; 16. History of alcohol abuse or illegal drug abuse within the past 12 months; 17. Potentially unreliable patients and those judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time period required for drug treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| time periods required for complete resolution of thyroid pain;percentage of relapse during treatment; | — |
Countries
China
Contacts
Public ContactGuan Qingbo
Shandong Provincial Hospital
Outcome results
None listed