A Phase 4 interventional study of Prednisone 1 week and Prednisone 6 weeks in Subacute Thyroiditis, sponsored by Xinqiao Hospital of Chongqing. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-05-20.
Sponsored by Xinqiao Hospital of Chongqing · Phase 4, Interventional, and Treatment
Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
The investigators hypothesize that less adverse reactions will be observed, comparing with the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent hypothyroidism aren't significant difference.
Comparing with the guidelines recommend, short-term (one week)prednisone and nsaids following up next week to treat moderate and severe subacute thyroiditis will be assessed.
The patients in wards will be assessed from temperature,erythrocyte sedimentation rate,C-reactive protein,local pain and goiter.The random treatment will be executed in moderate and severe SAT after informed consent be signed.
Subjects will be monitored once every 2 weeks.If patients complained of pain in their neck or if the erythrocyte sedimentation rate is still high,after discontinuation of prednisone, prednisone treatment will be resumed in moderate and severe subject and non-steroidal anti-inflammatory drugs will be used in mild subject.Anti-ulcer drugs will be administered to all patients.
The endpoint of the study are efficiency and safety of short-term prednisone treating. The investigators will assess adrenal insufficiency (such as anorexia, nausea, vomiting, abdominal pain),steroid withdrawal syndrome, recurrence rate and hypothyroidism. The investigators will observe erythrocyte sedimentation rate,pain,steroid level and thyroid function.
Xinqiao Hospital of Chongqing is the lead sponsor of 69 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.
Drug: Prednisone 1 week
Oral 30 mg/day of prednisone will be administered as the initial dose for the treatment of SAT in first week,then tapered by 5mg every 1 week,the duration of prednisone will be 6 weeks.
Drug: Prednisone 6 weeks
Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.
Also known as: Glucocorticoid
Guidelines recommend
Also known as: Glucocorticoid
The Efficiency of experimental group comparing with control group during 14 days
We will observe change of erythrocyte sedimentation rate from \>20mm/h to normal,C-reactive protein,pain and goiter disappear after 14 days.
Time frame: 14 days
recurrence rate
The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.
Time frame: 180 days
hypothyroidism
change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.
Time frame: 180 days
Adrenal insufficiency after withdraw in experimental group and control group.
The Symptom such as anorexia, nausea, vomiting, abdominal pain, fatigue, weakness, collapse, muscle pain, joint pain, weight loss, orthostatic hypotension, lethargy and depression.
Time frame: 42 days
Change of blood glucose in experimental group and control group.
Glucose change when taking medicine:from normal blood glucose on baseline to hyperglycemia at the special time during medication.
Time frame: 42 days
Change of blood pressure in experimental and control group during medication.
We will measure blood pressure before and after withdraw prednisone in experimental and control group.
Time frame: 42 days
Bone metabolism after withdraw in experimental group and control group.
We will measure Bone metabolism markers before and after withdraw prednisone in experimental and control group.
Time frame: 42 days
Change of Lipids in experimental and control group during medication.
We will measure Lipids before and after withdraw prednisone in experimental and control group.
Time frame: 42 days
Other side effects of prednisone
Such as,cushing appearance; female hirsutism, menstrual disorders, impotence in men; gastrointestinal ulcers; psychiatric symptoms: anxiety, agitation, fatigue
Time frame: 42 days
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glucocorticoid
Thyroiditis, Subacute
Xinqiao Hospital of Chongqing