Clinical trial NCT01837433: Short-term Prednisone to Treat STA Study(SPTSS)
Official title: Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subacute Thyroiditis
Keywords: Efficacy
safety
short
term
subacute thyroiditis
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 18-70 years patients with Moderate and severe subacute thyroiditis

Exclusion Criteria:

* adrenal cortical dysfunction,
* use of corticosteroids in nearly three months,
* mild subacute thyroiditis,
* non-onset STA,
* family history of diabetes,
* gastric ulcer,
* the special medication history,
* heart，liver and renal insufficiency,
* tumors,
* tuberculosis and
* poor compliance.

Primary outcomes:
measure: The Efficiency of experimental group comparing with control group during 14 days
timeFrame: 14 days
Secondary outcomes:
measure: recurrence rate
timeFrame: 180 days
measure: hypothyroidism
timeFrame: 180 days
measure: Adrenal insufficiency after withdraw in experimental group and control group.
timeFrame: 42 days
measure: Change of blood glucose in experimental group and control group.
timeFrame: 42 days
measure: Change of blood pressure in experimental and control group during medication.
timeFrame: 42 days
measure: Bone metabolism after withdraw in experimental group and control group.
timeFrame: 42 days
measure: Change of Lipids in experimental and control group during medication.
timeFrame: 42 days
Other outcomes:
measure: Other side effects of prednisone
timeFrame: 42 days
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Endocrinology, The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
name: Hongting Zheng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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