The comparative effectiveness between Individualised Homoeopathic Medicines and Calcarea Phosphorica 6X in cases of Vitamin D deficiency or insufficiency; An open-label, randomised clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum Vitamin D-25(OH) testing using Chemiluminescence Immunoassay (CLIA) technique
研究概览
简要总结
Total study duration is for a period of 18 months and each patient will be studied for a period of 3 months. Serum Vitamin D-25(OH) and serum calcium levels of each patient will be measured at baseline and after a period of 3 months. One arm will be given Calcarea Phosphorica 6x and another Individualised Homoeopathic Medicines out of which patients are selected randomly. Since it is an open study the researcher and patient are both aware of medication given. Patients are selected based on the inclusion and exclusion criteria as described. The total sample size is of 60 including a 20% dropout. The effectiveness of Calcarea Phosphorica 6x and Individualised Homoeopathic Medicines will be studied in this study. in case of any adverse events they will be recorded and reported as required.
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
- 10.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with serum Vitamin D-25(OH) less than 30ng per mL Patients of all religions and races irrespective of socioeconomic status Patients willing to take part in the study and for regular follow ups Patients who are willing to fill the respective consent forms.
排除标准
- •Patients with severe hepatic and renal diseases Patients with serum Vitamin D-25(OH) less than 5ng per mL Pregnant and lactating women.
- •Patients not willing to take part in study and regular follow ups.
- •Patients having any terminal disease condition.
- •Patients taking Vitamin D supplements or allopathic medicines for Vitamin D deficiency.
- •Patients taking Homoeopathic medicines within the last one month.
结局指标
主要结局
Serum Vitamin D-25(OH) testing using Chemiluminescence Immunoassay (CLIA) technique
时间窗: at baseline and after a period of 3 months
次要结局
- Serum Calcium testing(at baseline and after a period of 3 months)
研究者
Gurjeev Singh AL Gurcharan Singh
National Institute of Homoeopathy