An Open Label, Prospective, Interventional, Randomized, Multicentre, Two Arm Study to Evaluate Efficacy and Safety of Ferronomic Plus (Lactoferrin 50 mg + Disodium Guanosine 5-Monophosphate 5 mg + Ferrous Bisglycinate 30 mg + Folic Acid 200 mcg) in Comparison to Conventional Oral Iron Formulation in Pregnant Female with Iron Deficiency Anaemia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 4
研究概览
简要总结
A total of 150 female subjects with pregnancy at geographically distributed centres in India will be enrolled in this clinical study to evaluate the efficacy and safety of Ferronomic Plus (Lactoferrin 50 mg + Disodium Guanosine 5-Monophosphate 5 mg + Ferrous Bisglycinate 30 mg + Folic Acid 200 mcg) in comparison to conventional oral Iron formulation. Female subjects with physiological course of pregnancy, singleton pregnancy, gestational age > 12 weeks and < 36 weeks, hemoglobin (Hb) value of < 10 g/dL, serum iron < 50 mcg/dL and serum ferritin > 100 ng/mL at screening visit will be considered for enrollment in this study. The enrolled subjects will be allocated to either of the 2 study groups according to the computer-generated randomization plan in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects willing to provide written informed consent.
- •Subjects are willing and able to comply with all the protocol requirements including availability for all scheduled study visits.
- •Subjects with physiological course of pregnancy, singleton pregnancy, gestational age greater than 12 weeks and smaller than 36 weeks at the time of screening visit.
- •Subjects with hemoglobin (Hb) value of smaller than 10 g per dL at screening visit.
- •Subjects with serum iron smaller than 50 mcg per dL and serum ferritin greater than 100 ng per mL at screening visit.
排除标准
- •Subjects with history of allergic or hypersensitive reaction or intolerance to any of the ingredients of the study medication.
- •Subjects with gestational (such as hypertension, gestational diabetes) or pre-existent maternal diseases (such as thyroid dysfunctions, pituitary diseases, nutritional diseases, liver pathologies and fetal abnormalities (such as microcephaly, IUGR).
- •Subject has condition or is in a situation which, in the investigator’s opinion, may have put the subject at a significant risk, may have confounded study results, or may have interfered significantly with the subject’s participation in the study.
- •Subjects with known history of macrocytic or megaloblastic anemia due to vitamin B12 or folate deficiency.
- •Subjects with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Subject has used an investigational formulation in the 3 months prior to screening visit.
- •Subjects with suspected inability or unwillingness to comply with the study procedures.
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.