CTRI/2023/05/052772已完成4 期
AN OPEN–LABEL, MULTI-CENTRE, PHASE IV CLINICAL TRAIL TO DETERMINE THE SAFETY AND EFFICACY OF MICRONISED MICROENCAPSULATED FERRIC PYROPHOSPHATE (MMFP) IN PATIENTS WITH IRON DEFICIENCY ANEMIA
Ambtu Life Sciences Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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 with moderate iron deficiency anemia (Hb 7.5 -8.0 gm%; S. Male Ferritin < 15 mcg / ml) with CKD under treatment by a Nephrologist.
- •2. Female with moderate iron deficiency anemia (Hb 7.5 -8.0 gm%; S. Ferritin < 15 mcg / ml) under treatment by a gynecologist.
- •3. Age between 18 and 60 years.
- •4. Willing to give informed consent.
排除标准
- •1. Patient taking any iron supplement already at time of enrolment.
- •2. History of previous blood transfusion in the last 06 months.
- •3. Patient with Haemolytic anemia, Haemoglobinopathies, Myelodisplastic Syndromes and Neoplastic disorders.
- •4.Gastrointestinal surgeries that may impair iron absorption.
- •5. Patients with severe anemia (less than 6 gms%) requiring parenteral iron and / or blood transfusion.
- •6. Patients with cardiac, respiratory, neurological, gastro intestinal disease.
- •7. Female subjects demonstrating a positive pregnancy screen.
- •8. Patients diagnosed with severe gastritis, peptic ulcer, GI bleed or any other causes of pathological bleeding.
研究者
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