Clinical investigation of efficacy and safety of iron supplement in pregnant women affected by iron deficiency anemia.

Generex Pharmassist Pvt. Ltd.2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2022年11月21日最近更新: 2023年2月8日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Generex Pharmassist Pvt. Ltd.
入组人数: 50
试验地点: 2
主要终点: 1.Changes in hemoglobin levels between groups on screening and every follow up visit till end of the study

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The present research is an attempt to clinically validate the effectiveness of Iron supplement with different doses in pregnant patients suffering from iron deficiency anemia (IDA). With the present research, we can apply the knowledge from previous studies and clinical trials to address important medical needs in pregnant IDA to improve effectiveness and reduce the anticipated side effects with better compliance in improving IDA status. We can utilize these outcomes to develop a strategy for treating IDA in pregnant females in a more appropriate and assured way.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 40.00 Year(s)（—）
性别: Female

入选标准

•Pregnant females with age between 18-40 years (Both inclusive)
•Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between week 13 to week 20 (both inclusive)
•Female with primi or multigravida
•Pregnant females without any other comorbidity
•Hemoglobin levels between 9-10.5 gm/dl (Bothinclusive)
•With or without the fatigue associated with anemia
•Serum ferritin levels between 10-15 mcg/L (Both inclusive)
•Able to give written informed consent
•Able to follow up through visits.

排除标准

•1.Pregnant women of less than 13 weeks and more than 20 of gestation;2.Pregnant female with complicated pregnancy history or ongoing treatment for the same;3.Pregnant women with complications like bleeding piles, excessive emesis, active peptic ulcer, diabetes, hypertension, eclampsia, hypothyroidism and hyperthyroidism and multiple pregnancy;4.Fetal anomaly if detectable when an initial ultrasound is done to date the pregnancy; 5.Subjects on any concomitant therapy for treating IDA during study period 6.Not willing to provide consent or follow up; 7.Any condition from investigator viewpoint can affect patient participation in the study.

结局指标

主要结局

1.Changes in hemoglobin levels between groups on screening and every follow up visit till end of the study

时间窗: Screening, week 4, week 8,and week 12 and week 16

次要结局

1.Changes in Ferritin levels between groups on screening & every follow up visit till end of the study.(2.Changes in fatigue severity score between groups on screening & every follow up visit till end of the study.)

研究者

发起方

Generex Pharmassist Pvt. Ltd.

申办方类型

Pharmaceutical industry-Indian

研究点 (2)

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