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临床试验/NCT05545020
NCT05545020已完成2 期

Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Arthritis scored by DAS28 score

研究概览

简要总结

Trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. In addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease.

So this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.

详细描述

Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. Trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • rheumatoid arthritis

排除标准

  • other autoimmune diseases

研究组 & 干预措施

Trivalent chromium

Active Comparator

A dietary supplement already available in market one of its known uses is to control diabetes.

干预措施: Trivalent chromium versus synthetic and/ or biological DMARDs (Drug)

Immunesuppressants

Active Comparator

Synthetic and/ or biological DMARDs

干预措施: Trivalent chromium versus synthetic and/ or biological DMARDs (Drug)

结局指标

主要结局

Arthritis scored by DAS28 score

时间窗: three months

DAS 28 is a score of arthritis

ESR in mm/hr

时间窗: three months

lab measures for disease activity

CRP mg/dL

时间窗: three months

lab measures for disease activity

Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)

时间窗: three months

To assess joints and bone

次要结局

  • Serum urea(three months)
  • serum creatinine(three months)
  • SGOT(three months)
  • SGPT(three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sally Saad Saad Hassouna

Lecturer of Internal Medicine department, Rheumatology and Immunology Unit

Alexandria University

研究点 (1)

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