A Clinical Comparative study to evaluate the safety and efficacy of Himfera capsules in the Management of Iron Deficiency Anaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in anaemia-related blood parameter levels
研究概览
简要总结
This will be a comparative clinical study consisting of 40 subjects who fulfil the subject selection. According to the study, all the subjects will be advised to take 1 Himfera capsules or standard iron supplement which will be coded during the study as Himfera A or B twice daily for a period of 2 months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of both sexes in the age group of 18-70 years with Hemoglobin <11gm/dL.
- •Subjects who have clinical symptoms such as pale skin colour, extreme fatigue, irritability, weakness, brittle nails, palpitation, headache, loss of appetite.
- •Subjective improvement in quality of life in subjects with Iron deficiency anaemic.
- •Subjects willing to give written informed consent.
排除标准
- •Subjects with hemoglobin concentration < 6 gm/dl, patients of thalassaemia, sickle cell anemia, aplastic anemia, haemolytic anemia, lead poisoning, sideroblastic anaemia, malignancies, congenital.
- •Blood hemoglobin level < 5 gm/dl during the course of any treatment, any other acute illness, severe untoward effect.
- •Absence of iron binding protein, hereditory spherocytosis and any association of severe complication.
- •Pregnant & lactating women.
- •Not willing to sign informed consent form.
结局指标
主要结局
Change in anaemia-related blood parameter levels
时间窗: Patients will be followed up and the results were assessed from baseline on visit days: | Visit 0- Baseline | Visit 1 - At the end of Month 1 | Visit 2- At the end of Month 2 (End of the study)
An improvement in biochemical parameters viz. serum iron hemoglobin levels and erythrocyte counts.
时间窗: Patients will be followed up and the results were assessed from baseline on visit days: | Visit 0- Baseline | Visit 1 - At the end of Month 1 | Visit 2- At the end of Month 2 (End of the study)
Improvement in symptoms such as skin pallor, tiredness and lack of energy, headache, weakness, low performance, appetite, breathlessness and feeling of wellbeing.
时间窗: Patients will be followed up and the results were assessed from baseline on visit days: | Visit 0- Baseline | Visit 1 - At the end of Month 1 | Visit 2- At the end of Month 2 (End of the study)
Subjective improvement in quality of life in subjects with Iron deficiency anaemic.
时间窗: Patients will be followed up and the results were assessed from baseline on visit days: | Visit 0- Baseline | Visit 1 - At the end of Month 1 | Visit 2- At the end of Month 2 (End of the study)
次要结局
- Compliance of the subject to the drug treatment and the adverse effects will be noted.(Patients will be followed up and the results were assessed from baseline on visit days:)