Evaluation of the effect of neem leaves(Azadirachta indica) in patients with iron deficiency anemia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of neem leaves in increasing haemoglobin concentration (Hb%), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), and mean corpuscular haemoglobin concentration (MCHC) in patients with iron deficiency anaemia.
研究概览
简要总结
Iron deficiency anaemia is one of the most common nutritional disorders in India, affecting a significant proportion of adults, especially women. Although oral iron supplementation is the standard treatment, it is commonly associated with gastrointestinal side effects leading to poor compliance. Neem (Azadirachta indica) leaves have demonstrated hematinic potential in animal and in-vitro studies.
This interventional study aims to evaluate the effect of daily consumption of fresh neem leaves on haemoglobin levels and other haematological parameters in patients with iron deficiency anaemia. Thirty participants aged 18–45 years with haemoglobin less than 10 g/dL will be enrolled and divided into two groups. The study group will receive one fresh neem leaf daily on an empty stomach for 15 days, while the comparator group will receive oral ferrous sulphate supplementation for the same duration.
Haematological parameters including haemoglobin percentage, RBC count, hematocrit, MCV, MCH, MCHC, RDW, and peripheral smear findings will be assessed before and after the intervention. The study intends to determine whether neem leaves can serve as a potential alternative or adjunct therapy in the management of iron deficiency anaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •The subjects suspected with iron deficiency anaemia with less than 10 gm% of hemoglobin concentration.
- •The subjects who are in the age group of 18-45 years.
排除标准
- •Patients who have taken iron supplements within the last six months will be excluded from the study.
- •Patients with comorbid conditions or any other hematological abnormalities will also be excluded from the study.
结局指标
主要结局
To evaluate the efficacy of neem leaves in increasing haemoglobin concentration (Hb%), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), and mean corpuscular haemoglobin concentration (MCHC) in patients with iron deficiency anaemia.
时间窗: 30 days
次要结局
未报告次要终点
研究者
Anushree R Havale
Navodaya Medical College Hospital and Research center