CTRI/2020/12/029778尚未招募4 期
Evaluation of efficacy and safety of Micellar Iron in the treatment of Iron Deficiency Anaemia patients: A prospective, randomised, double-blind, single centre, placebo-controlled, interventional study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
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
入选标准
- •1. Male and female subjects aged 18 years and above.
- •2. Male subjects with haemoglobin level below 13.0 g/dL and female subjects with haemoglobin level below 12.0 g/dL.
- •3. Subjects willing to provide informed written consent.
排除标准
- •1. Pregnant, planning to become pregnant or breastfeeding women.
- •2. Subjects with anaemia other than iron deficiency anaemia.
- •3. Subjects have undergone blood transfusion or underwent iron therapy in the last three months.
- •4. Subjects with microcytic iron-overloading disorder (thalassemia, sideroblastic anemia)
- •5. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
- •6. Alcohol or substance abuse
- •7. Allergy or sensitivity to any of the ingredients in the study treatment
- •8. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly
- •9. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
研究者
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