Prospective randomised clinical trial to evaluate the effectiveness of trinitrotoluenum 200c in comparison with individualised homoeopathic medicines in anaemia and in vitro antioxidant assay
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The response of the patients will be observed and changes in the haemoglobin level before and after the intervention will be assessed
研究概览
简要总结
Anaemia is defined as a condition in which there is quantitative or qualitative or both deficiency of red blood cell or haemoglobin in circulating blood. WHO estimates worldwide that 40% of children aged 6 to 59 months 37% of pregnant women and 30%of women aged 15 to 49 years are affected by anaemia. Research question is trinitrotoluenum 200c effective in the treatment of anaemia in comparison with individualised homoeopathic medicines and has antioxidant property. Null hypothesis is there is no significant change in the levels of haemoglobin treated with Trinitrotoluenum 200c in comparison with individualised homoeopathic medicine for 6 months.Alternative hypothesis there is significant change in the levels of haemoglobin treated with Trinitrotluenum 200c in comparison with individualised homoeopathic medicine for 6 months. The aim of this study is to determine the effectiveness of Trinitrotoluenum 200c in comparison with individualised homoeopathic medicine in the treatment of anaemia and to assess the antioxidant properties.The primary objective is to compare the pre and post treatment effect of Trinitrotoluenum 200c and individualised homoeopathic medicines in patients suffering from anaemia through randomised clinical trial.Secondary objective is identification of antioxidant properties of trinitrotoluenum 200c by antioxidant assay.It is a prospective randomised clinical trial conducted at the OPD setting of National Institute of Homoeopathy Kolkata where each case will be taken in detail appropriate consent taken and patient will be enrolled. Adequate dietary modifications will be advised for good results.Appropriate statistical tools will be used and data analysed at the end of the study.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age groups 18-60 of both sex and religion Persons with more than 7 out of 14 clinical signs and symptoms of anaemia Cases with haemoglobin concentration less than 12g per dl in males and less than 11.5g per dl in females Patients willing to give written consent for participating in the study and complete follow up during study Patients who are able to read Bengali or English or Hindi.
排除标准
- •Age below 18 and above 60 Cases with haemoglobin concentration less than 7g per dl Cases with serious illness like chronic kidney disease malignancy heart diseases Pregnant and lactating mothers Immunocompromised patient Patient suffering from any severe psychiatric illness Patient not willing to give written consent Patients not willing to undergo any investigation if needed.
结局指标
主要结局
The response of the patients will be observed and changes in the haemoglobin level before and after the intervention will be assessed
时间窗: Baseline and 6 months
次要结局
- Identification of antioxidant properties of Trinitrotoluenum by antioxidant assay(3 months)
研究者
Dr Alin Sara Alex
National Institute of Homoeopathy