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临床试验/CTRI/2023/01/048783
CTRI/2023/01/048783尚未招募未知

Investigation of efficacy and safety of different iron supplementations in nonanemic to mild anemic adults with iron deficiency and suffering from fatigue. - Nil

Meyer Organics Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

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.Adult male and females with the age between 18-65 years old (Both inclusive);
  • 2.Subjects presenting with fatigue scoring between 18 to 54 based on-Fatigue Severity Scale (FSS) at screening;
  • 3.Serum ferritin levels lower than 50 mcg/L (iron deficiency);
  • 4.Hemoglobin levels =11 g/dL in non-pregnant women and men (mild anemic to non-anemic patients, defined by WHO);
  • 5.Subjects with or without comorbidity, if comorbid, should be with stable prescription for last three months;
  • 6.Able to give written informed consent;
  • 7.Able to follow up through visits.

排除标准

  • 1.Previous diagnosis of any concurrent disease or medical and/or surgical condition as a possible cause of fatigue or iron deficiency;
  • 2.Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.).
  • 3.Medical history of malabsorption syndrome, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy;
  • 4.Patients who are eligible for IV iron replacement therapy.
  • 5.Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator
  • 6.Any treatment with any vitamin and mineral supplements prior to inclusion to the study in the last 3 months’ period;
  • 7.Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m raise to 2
  • 8.Ongoing or history of malignancy within past 3 years;
  • 9.Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 4 weeks postpartum, or have a positive serum/urine pregnancy test;
  • 10.Known or suspected hypersensitivity to iron or any of the components of investigational products;
  • 11.Not being competent to complete study questionnaires as per discretion of investigator.

研究者

发起方
Meyer Organics Pvt Ltd

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