A community-based study on the effectiveness and acceptance of Drakshavaleha for anaemia in selected districts of the Vidarbha region, Maharashtra
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 8,300
- 试验地点
- 1
- 主要终点
- Change in mean haemoglobin levels from baseline to the end of 12th weeks
研究概览
简要总结
Anaemia, defined as a reduction in the haemoglobin concentration of the blood, is a widespread public health issue, particularly in developing countries. In India, anaemia continues to be a major concern, affecting children, adolescents, and adults. It leads to fatigue, poor work performance, impaired cognitive and physical development, and, in severe cases, can result in maternal and perinatal mortality. Anaemia is classified as being mild, moderate or severe based on the extent of haemoglobin deficiency. The majority of anaemia in India is categorised as mild or moderate, with under 3 percent of women and children being reported as severely anaemic. However, even mild and moderate anaemia, if left untreated, can lead to serious long-term health consequences.
As per the National Family Health Survey (NFHS-5, 2019–21), the prevalence of anaemia among women aged 15–49 years in Maharashtra is 57percent, and among children aged 6–59 months, it is 67.1percent. These statistics highlight the need for effective and community-based interventions. Ayurvedic medicines like Classical Ayurveda medicines like Punarnavadi mandoor, Dhatri lauha, Drakshavaleha, etc. are known to have their role in increasing hemoglobin and improving the symptoms associated with anaemia.
Aim of the study is to assess the effectiveness of Drakshavaleha on anemia among adults in selected districts of the Vidarbha region, Maharashtra
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •i) Individuals of any gender, age above 18 years ii) Hb 8-11.9 in women and 8-12.9 in men iii) Willing to take the Ayurveda intervention for 3 months.
排除标准
- •Pregnant women
- •Known cases of Diabetes mellitus
- •Known cases of any Hemoglobinopathies, bleeding disorders, serious systemic illnesses like malignancy,
- •Individuals having a family history of hemoglobinopathies and history of blood transfusion in the last 6 months.
结局指标
主要结局
Change in mean haemoglobin levels from baseline to the end of 12th weeks
时间窗: At the end of 12th weeks
次要结局
- Change in mean score of the FACIT-Fatigue Scale from baseline to the end of 12 weeks(At the end of 12th weeks)
- Proportion of participants showing treatment adherence equal to and more than 70%(At the end of 4th,8th & 12th weeks)
- Participant satisfaction with intervention (measured through end-line interview)(At the end of 12th weeks)
- Proportion of men with Hb gm% equal or more than 13 and women with Hb gm % equal or more than 12 after three months of Ayurveda intervention(At the end of 12th weeks)
研究者
Dr Kalpana Kachare
Central Council for Research in Ayurvedic Sciences