Evaluating The Effectiveness Of Individualized Homoeopathic Medicines In Cases Of Vitamin B12 Deficiency Or Insufficiency; An Open-Label, Prospective, Interventional Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- For each enrolled case, the serum Vitamin B12 levels will be recorded at baseline
研究概览
简要总结
Vitamin B12 is a water soluble vitamin which contains the mineral cobalt. Hence, compounds with vitamin B12 activity are collectively called cobalamins. It plays a crucial role in several vital processes in the body including development, myelination, and function of the central nervous system, healthy red blood cell formation, and DNA synthesis. Vitamin B12 deficiency refers to a condition in which the serum concentration of vitamin B12 (cobalamin) falls below the normal physiological range, leading to impaired DNA synthesis, haematopoiesis, and neurological function. It is typically defined biochemically as serum vitamin B12 level less than 200 pg/mL and borderline deficiency (insufficiency) 200–300 pg/mL. The primary objective of this study is to compare the changes in serum Vitamin B12 levels in cases of Vitamin B12 deficiency or insufficiency when Individualized Homoeopathic Medicine is used as an intervention over a period of 3 months. A minimum of 41 patients will be enrolled. A follow up of each case will be taken on a monthly basis for a period of 3 months and serum vitamin B12 will be checked at baseline and after 3 months.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients with serum Vitamin B12 levels less than or equal to 300 pg/mL b) Patients between 18-70 years of age, all sexes, all religions and races irrespective of socioeconomic status.
- •c) Patients willing to take part in the study and fill the respective consent forms.
排除标准
- •a) Patients under use of medications affecting vitamin B12 levels – Metformin, proton pump inhibitors, H2 blockers.
- •b) Patients under the use of vitamin B12 supplements.
- •c) Patients with chronic alcoholism or substance abuse.
- •d) Pregnant and lactating women.
- •e) Patients having any terminal disease condition.
结局指标
主要结局
For each enrolled case, the serum Vitamin B12 levels will be recorded at baseline
时间窗: 0 month, 3 months
and then again after 3 months using Chemiluminescence Immunoassay (CLIA) technique and its changes
时间窗: 0 month, 3 months
will then be observed and recorded. The efficacy of Individualized Homoeopathic Medicines will be seen
时间窗: 0 month, 3 months
in the cases of Vitamin B12 deficiency or insufficiency.
时间窗: 0 month, 3 months
次要结局
未报告次要终点
研究者
Dr Bodu Sanghavi
National Institute of Homoeopathy, Kolkata