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临床试验/CTIS2022-500922-13-00
CTIS2022-500922-13-00进行中(未招募)1 期

Thiamine against chronic rheumatoid arthritis fatigue

Aarhus University Hospital0 个研究点目标入组 40 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Rheumatoid arthritis diagnosed > 3 months ago., In remission/mild disease activity (CRP < 10 mg/l, MD-HAQ < 1,3, DAS28 < 3,2), Chronic fatigue (duration of fatigue = 6 months, BRAF total fatigue score = 16), Age =18 years, Signed informed consent, Anticontraceptive (People who can get pregnant will need to use a safe anticontraceptive during the trial (12 weeks). Safe anticontraceptive is defined as: combination pills, intrauterine device, depot injection, subdermal implant, hormonal vaginal ring, or transdermal depot patch)

排除标准

  • Patients with co-morbidity which can explain the participants fatigue, including: Anaemia (haemoglobin < 7,1 mmol/l [female]; < 8,1 mmol/l [male], Iron deficiency (Ferritin < 30 µg/l), Vitamin B12 deficiency (Vitamin B12 <125 pmol/l), Folate deficiency (Folate < 9 nmol/l), Vitamin D deficiency (25-Hydroxy-Vitamin D[D3+D2] < 50 nmol/l), Diabetes (HbA1c = 48 mmol/mol or medication), Hypo/hyperthyroidism (TSH <0,300 or > 4,5 IU/l or medication), Participants who are unable to cooperate and follow the protocol, Pregnant patients

研究者

发起方
Aarhus University Hospital

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