CTRI/2019/01/017303已完成3 期
To evaluate the efficacy, safety, and tolerability of Abhraloha in women compared with oral Ferrous Ascorbate in iron deficiency anemia - Randomized controlled, parallel group, assessor blind clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
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.Women >18 years to <65 years old.
- •2.Women diagnosed with iron deficiency anemia (criteria stated in Annexure 1) and Hb<=10 g/dL and >7gm/dl and serum ferritin <30ug/L
- •3.Women in postpartum period 10 days after delivery
- •4.Women with negative urine pregnancy test.
排除标准
- •1.Women with significant vaginal bleeding (estimated blood loss greater than 100 cc) in the 24 hours prior to randomization
- •2.Women with a history of anemia other than iron deficiency anemia or anemia due to blood loss due to delivery.
- •3.Women on current treatment with myelo suppressive therapy or asthma therapy
- •4.Women with recent blood transfusions, or erythropoietin within 3 months prior to screening.
- •5.Women with history of bleeding tendency, history of blood transfusion within the prior 120 days, hemoglobinopathy or other red cell disorders.
- •6.Women with serum transaminases, total protein and albumin >1.5 upper limit of normal
- •7.Women with serum creatinine >1.5 mg/dl
- •8.Women with known Intolerance to iron derivatives
- •9.Women with history of alcohol or drug abuse, bleeding disorder
- •10.Women having any severe active infectious disease requiring hospitalisation.
- •11.Women who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness.
- •12.Women with known history of positive screening result for hepatitis B and/or Hepatitis C virus.
- •13.Women with history of HIV or any immunodeficient conditions.
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