Subacute thyroiditis
Conditions
Interventions
Experimental group:15 mg initial dosage of prednisolone daily
Control group:15 mg initial dosage of prednisolone daily
Sponsors
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Diagnosed with subacute thyroiditis with severe pain or who fail to respond to full doses of nonsteroidal anti-inflammatory agents. 3. Men and women (non-pregnant and using a medically approved birth-control method) aged between 18 and 70 years at screening. 4. Willing to participate in the present study and not permitted to be involved in another trial within 3 months.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods. 2. Diagnosis suspected or history of: a. Acute thyroiditis, b. Grave's disease, c. Hashimoto thyroiditis, d. Thyroid carcinoma. 3. Allergy or intolerance with NSAIDs or glucocorticoids. 4. Treatment with systemic glucocorticoids (oral, intravenous) for more than consecutive 7 days within the past 6 months. 5. Adrenocortical hyperfunction, uncontrolled hypertension, or uncontrolled diabetes. 6. Patients with clinically apparent liver disease characterized by either one of the following: a. ALT or AST > 3x upper limit of normal (ULN) confirmed on two consecutive measurements (by local laboratory) within 4 weeks prior to screening period. b. Impaired excretory (e.g. hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices. c. 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 = 60 mL/min calculated by using the abbreviated equation developed by the Modification of Diet in Renal Disease (MDRD) study with modification for the Chinese population) at screening or within 4 weeks prior to screening (by local laboratory) 8. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV. 9. Significant cardiovascular history within the past 3 months prior to 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. Mental disorders or epilepsy. 11. Corneal ulcer; 12. History of gastrointestinal disease including gastroenterostomy, enterectomy, Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer. 13. Post-operation with unhealing incision. 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 (AIDS). 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 |
|---|---|
| Time required for PSL treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for resolution of thyroid pain;Time for remission of thyroid pain;Time for normalization of thyroid function; | — |
Countries
China
Contacts
Public ContactShaoyong Xu
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Outcome results
None listed