CTRI/2011/10/002097招募中4 期
Randomized controlled trial of evaluation of safety, efficacy and pharmacoeconomics of sodium feredetate and ferrous fumarate in the iron deficiency anemia (IDA) in a tertiary care hospital in central India
none0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
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. Children of either gender age group 9-12 years with mild, moderate IDA
- •2. Adult age group >12-50 years with mild and moderate IDA
- •3. Serum creatinine less than 1.5 mg/dl at screening
- •4. Hb level <11.5 in children(5-11 yrs), <12 in children (12-14 yrs) & non-pregnant women, <13 in adult men
- •5. Serum ferritin <15 µg/l
- •6. Obtained written informed consent
排除标准
- •1. Severe anaemia ( <8gm/dl).
- •2. Pregnant females and Lactating mothers.
- •3. Patients with bleeding piles, mennorrhagia, chronic diarrhea.
- •4. Patient taking any interacting drug affecting iron absorption like antacids, ascorbic
- •acids, antibiotics (tetracycline, quinolones)
- •5. S. Creatinine >1.5 mg/dl
- •6. Known hypersensitivity to any components of sodium feredetate or ferrous fumarate
- •7. Pregnant or sexually -active females who are of childbearing potential and who are
- •not willing to use an acceptable form of contraception
- •8. Alcohol or any drug abuse within past six months
- •9. Any other laboratory abnormality, medical condition or psychiatric disorders which
- •put the subjectâ??s disease management at risk or may result in the subject being
- •unable to comply with the study.
研究者
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