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临床试验/ISRCTN58259979
ISRCTN58259979已完成2 期

Double-blind, randomized, placebo-controlled trial of alpha-lipoic acid for fibromyalgia

Physicians Services Incorporated Foundation0 个研究点目标入组 27 人开始时间: 2016年3月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
27

研究概览

简要总结

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged 18 and older
  • 2. Meeting the 2010 American College of Rheumatology diagnostic criteria for fibromyalgia
  • 3. Experienced at least moderate daily pain (Numerical Rating Scale = 4/10) for at least 3 months prior to study entry
  • 4. AST (aspartate aminotransferase)/ALT (alanine aminotransferase) no greater than 20% the upper limit of normal
  • 5. Serum creatinine no greater than 50% the upper limit of normal
  • 6. Necessary abilities, visual acuity and language skills for pain diary completion and telephone communication with study nurses

排除标准

  • 1. Any major organ system disease
  • 2. Major poorly controlled psychiatric disorder
  • 3. Severe depression or suicidal ideation
  • 4. Active substance abuse disorder
  • 5. Lactose intolerance
  • 6. Hypersensitivity to ALA
  • 7. Painful condition more than 50% as severe as their fibromyalgia pain
  • 8. Unwillingness to use a highly effective form of contraception (women of childbearing potential)

研究者

发起方
Physicians Services Incorporated Foundation

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