Role of Oleum jecoris aselli 3x in Iron deficiency anemia associated with Hypovitaminosis D – a single arm prospective clinical study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes in Hemoglobin level
研究概览
简要总结
This study is a single arm, prospective clinical interventional study to determine the role of Oleum jecoris aselli 3X in iron deficiency anemia associated with Hypovitaminosis D that will be conducted by considering the patient presenting with symptoms like weakness, muscle cramps, joint pains, hairfall and other features of IDA and Hypovitaminosis D consulting the outpatient and inpatient department, peripheral centers, special camps of National Homoeopathy Research Institute in Mental Health, Kottayam.The primary outcome measure will the changes in the hemoglobin level, assessed every month. The secondary outcome measures will be the changes in the serum ferritin level and 25[OH]D level, assessed before and after treatment. Liver function tests will be done once in 3 months to check for the toxicological effects(if any) after repeated administration of medicine in 3X potency.This study aims to make the efforts to offer possibilities for future research in identifying the role of Oleum jecoris aselli 3X in the management of iron deficiency anemia and Hypovitaminosis D individually as well as in association.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients from 18 to 60 years of age and both genders.
- •2.Patients with Hemoglobin level 8 to 12g/dl in females and 8 to 13g/dl in males and Serum ferritin level less than 30µg/L.
排除标准
- •1.Patients with severe anemia with Hemoglobin level less than 8g/dl.
- •2.Patients with other types of anemia.
- •3.Patients who are already taking any vitamin D or iron supplementation.
- •4.Pregnant and lactating women.
- •5.Patients with other known severe systemic illnesses like uncontrolled diabetes, Malignant Hypertension, Severe cardiac diseases, and Malignancies.
- •6.Immuno-compromised patients- HIV/AIDS, TB.
结局指标
主要结局
Changes in Hemoglobin level
时间窗: Every month till the conclusion of study (6th month)
次要结局
- Changes in the serum ferritin level and 25[OH]D level(Baseline and at the conclusion of the study(6th month))
研究者
Dr Sowndarya S
National Homoeopathy Research Institute in Mental Health