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Clinical Trials/ISRCTN81818883
ISRCTN81818883
Completed
未知

Double-blind, randomised, placebo-controlled pilot study of LC in systemic lupus erythematosus

Department of Health (Taiwan) - Executive Yuan0 sites90 target enrollmentApril 11, 2008

Overview

Phase
未知
Intervention
Not specified
Conditions
Systemic lupus erythematosus (SLE)
Sponsor
Department of Health (Taiwan) - Executive Yuan
Enrollment
90
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 11, 2008
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Department of Health (Taiwan) - Executive Yuan

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients fulfill the revised American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE)
  • 2\. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI\-2K) score more than or equal to 2 and less than or equal to 36
  • 3\. Daily dose of prednisolone less than or equal to 0\.6 mg/kg
  • 4\. Age more than or equal to 7 years old and body weight more than or equal to 40 kg, either sex

Exclusion Criteria

  • 1\. Alcoholism
  • 2\. Diabetes mellitus
  • 3\. Life\-threatening disease
  • 4\. Pregnant or nursing women
  • 5\. Creatinine clearance less than or equal to 25 cc/min
  • 6\. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than or equal to 2 x normal limit

Outcomes

Primary Outcomes

Not specified

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