Effectiveness of Ferrum phosphoricum 6x in Increasing Haemoglobin Levels in Anaemia among the Women of Reproductive Age Group: A comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Haemoglobin level
研究概览
简要总结
Anemia is a condition where the number of RBCs or their oxygen-carrying capacity decreases to the extent to meet the physiologic needs, and is conventionally taken as a hemoglobin (Hb) value of less than two standard deviations (SD)than the median value for healthy matched population by age, sex, altitude, smoking, and pregnancy status. Among the various causes, nutritional deficiency, especially iron deficiency, is the most common cause of anemia. Regarding the strategies for correcting IDA (Iron Deficiency Anaemia) at the community level, we have a few options available alone or in combination: education combined with dietary modification or diversification, or both, to improve iron intake and bioavailability; iron supplementation and iron fortification or bio-fortification of foods. Oral iron supplementation has limitations, including side effects, non-compliance, and taking a longer time to correct anemia. Homoeopathy can bridge the gap to reduce the burden of IDA due to its acceptability in the general population and cost-effectiveness. Though there are some encouraging pre-clinical as well as clinical trial, evidences favoring the role of Ferrum phosphoricum in IDA, but studies with proper methodology, larger sample sizes and proper statistical evaluation still miniscule in this subject to draw any definite conclusion. Therefore, a double-blind, randomized controlled trial in a pragmatic setup is required to evaluate the efficacy of FP in IDA over the placebo. But before that, it requires clear clarification whether FP will be useful in anaemia (specific) universally or only when applied according to the indications of this medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Female aged 18-45 years,
- •Diagnosed case of Anaemia with Haemoglobin level more than or equal to 8 gm per dl to less than 12 gm per dl
- •Willing to give consent to participate in the study.
排除标准
- •Patients unable to give informed consent or unwilling to take part in the study.
- •Pregnant and lactating mother
- •Patients who are self-reported immune-compromised.
- •Patients with any self-reported haemoglobinopathies like Thalasaemia, Sickle cell anemia etc.
- •Patients suffering from Anaemia with chronic illnesses like diabetes, cardiac complications, renal failure etc.
- •Patient with psychiatric disorder and or history of substance abuse
- •Patient under homoeopathic treatment for any chronic disease within last 1 month.
- •Patient who are already under Iron supplementation in last 1 month before the enrollment.
结局指标
主要结局
Haemoglobin level
时间窗: At the baseline and at the end of each month till 3 months of follow-up.
次要结局
- Serum biochemical markers, Serum ferritin, Transferrin, TIBC(At the baseline and at the end of 3rd month)
- Quality of life SF36 Score(At the baseline and at the end of every months till 3 months)
研究者
Madhumita Sadhukhan
Central Council for Research in Homoeopathy
