Therapeutic effects of Lecithinum on red blood cells and haemoglobin concentration in iron deficiency anaemia of reproductive females: A randomized, double blind placebo- controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To observe the hemoglobin percentage through complete hemogram in each sample
研究概览
简要总结
The World Health Organization defines anaemia as a condition in which the number of red cells or their oxygen-carrying capacity is insufficient to meet physiological requirements. Rates of iron deficiency anaemia in women of childbearing age exceed this due to menstruation and pregnancy-related blood loss. While lecithin has a significant effect in increasing red blood cell (RBC) and haemoglobin (Hb) percentages, but our extensive search on lecithin studies revealed limited available data. Therefore, we aim to conduct an randomized research study at The Calcutta Homoeopathic Medical College and Hospital, with targeted sample size of 240, to investigate the potential significant improvement in anemic women through homoeopathic medicine lecithinum. Primary outcome is to observe the hemoglobin percentage and secondary outcopme is to observe the structural change in RBC, RBC count, and to measure Fatigue Severity using Fatigue Severity Score (FSS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Reproductive age group: 18-49 years.
- •Patients suffering from iron deficiency anaemia confirmed by Hb% 7-12 gm/dl and serum ferritin level less than 30 ng/mL.
- •Only female sexes
- •Person not taking any other homoeopathic medicines for last 4 weeks.
- •Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
- •Literate participant able to read and write in English, Hindi or Bengali
- •Participants providing with written informed consent.
排除标准
- •Patients with haemoglobin less than 7 gm/dL (severe anaemia)
- •Diagnosed case of unstable mental or physical illness or other uncontrolled systemic illness or life- threatening infections (e.g., malignancy) affecting quality of life or any vital organ failure.
- •Pregnant, puerperal and lactational women
- •Any substance abuses
- •Self-reported immune – compromised state
- •Patients who are too sick for consultation
- •Simultaneous participation of any other clinical trials
- •Undergoing homoeopathic treatment for any chronic disease within last 6 month.
结局指标
主要结局
To observe the hemoglobin percentage through complete hemogram in each sample
时间窗: Hemoglobin percentage at baseline and every months, till 3 months in each sample
次要结局
- To observe the structural change in RBC, RBC count, and to measure Fatigue Severity using Fatigue Severity Score (FSS)(2 years or till the sample sized achieved)
研究者
DR RUPALI BHADURI
The Calcutta Homoeopathic Medical College and Hospital