CTRI/2023/07/055267已完成Unknown
A double-blind, randomized, comparative clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement/adjuvant to the treatment. - Anemia
YourZooki holdings 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
- Unknown
- 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
- •Patients of either gender 18 to 70 years (inclusive)
- •Subjects giving written informed consent /assent form
- •Patients having presence of iron deficiency anemia below normal or low hemoglobin as per lab reports.
- •Non-use of any iron supplement for 2 weeks prior to enrolment to the study and to know the dosage timing of Calcium supplement if any.
- •Willing to come for regular follow-up visits.
- •In the opinion of the investigator, able to comply with the requirements of the protocol.
排除标准
- •Patients with serious cardiovascular, cerebro-vascular respiratory liver or renal disease or any other disorder.
- •Known history of hypersensitivity to herbal extracts or dietary supplements. Known or suspected hypersensitivity to iron or any of the components of Investigational Product.
- •Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy.
- •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.).
- •Evidence of alcohol or drug abuse, that may, in the opinion of the Investigator interferes with study compliance or prevents understanding of the objectives, investigational procedures or possible consequences of the study.
研究者
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