Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-05 @ 3:00 PM
Study NCT ID:
NCT01837433
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2013-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Prednisone to Treat STA Study(SPTSS)
Sponsor:
Xinqiao Hospital of Chongqing
Organization:
Study Overview
Official Title:
Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STA
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: