ACTRN12623001349639招募中1 期
Assessing the efficacy and safety of 6-Shogaol in improving cytopenias of patients with lower risk Myelodysplastic Syndromes – a pilot clinical trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Confirmed diagnosis (using standard French-American-British (FAB) criteria) of MDS
- •MDS patients belonging to low, Int-1 risk disease by IPSS criteria life expectancy greater than 3 months
- •Newly diagnosed as well as previously treated patients with de novo or secondary MDS will be eligible.
- •Performance Status 0-2 using Eastern Cooperative Oncology Group (ECOG) scale
- •Serum ferritin on screening pathology greater or equal to 100 ug/L
排除标准
- •MDS treatments
- •Previous treatment with chemotherapy, chelation therapy hematopoietic growth factors, erythropoietin, or cytokines within the 4 weeks prior to starting the IMP
- •Planned treatment with chemotherapy, chelation therapy, hematopoietic growth factors, erythropoietin, or cytokines during the course of the trial
- •Concomitant use or planned concomitant use of recombinant erythropoietin or platelet stimulating factors during the trial
- •Concomitant use or planned concomitant use of any other experimental agent aimed at treating MDS during the trial
- •Medical History
- •An active, clinically significant infection that is not effectively controlled with antimicrobial or antiviral therapy
- •Current, clinically significant active cardiac disease, including congestive heart failure
- •Current, clinically significant renal disease
- •Current, clinically significant bleeding disorder
- •Known allergy to ginger or ginger-based products
- •Mental Health
- •Severe mental illness
- •Medications
- •Concomitant use of any medication with a known, clinically significant interaction with the IMP (e.g. anti-diabetic drugs, calcium channel blockers, cyclosporine, metronidazole)
- •Regular, concomitant use of prescription anticoagulant medications such as warfarin, Eliquis, Pradaxa, Lixiana and Xeralto. (Sporadic PRN use of aspirin is permissible. Regular low dose aspirin ( less then or equal to 100mg per day) is permissible. Supplements with anticoagulant properties are permissible)
- •Pregnant or breast-feeding
- •Pathology abnormalities
- •Clinically significant abnormality on any pre-existing ECG
- •Liver function tests greater than 2 times ULN AND of clinical significance
- •BUN and or Creatinine greater than 2 times ULN AND of clinical significance
研究者
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