An Observational study to assess the levels of Mercury and Arsenic in the patients of Kitibhakushtha receiving Arogyavardhini vati and Rasamanikya
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- 1. To assess the levels of mercury and arsenic levels in serum and urine samples of Kitibhakushtha patients during and post-intervention of study drugs
研究概览
简要总结
This study is a single arm open labelled observational study for assessing the serum and urine levels of mercury and arsenic in 55 patients of Kitibha kustha prescribed with Arogyavardhini vati and Rasamanikya (Herbo-mineral preparations) for 3 months with 1 month of follow-up. The primary outcome of the study would provide evidence-based Clinical safety data of Arogyavardhini Vati and Rasamanikya at therapeutic dose levels along with Validation of the Standard manufacturing procedure of study drugs as a secondary outcome.
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
- •Duration: Up to 10 years chronicity Patients of Plaque Psoriasis Patients having the clinical features of Kitibhakushtha (mild to moderate Psoriasis) with PASI score up to 10, BSA up to 3 %) Patients not taking any other Ayurvedic intervention in the last 6 months.
- •Fresh cases of Kitibhakushtha on prescribtion of Arogyavardhini Vati and Rasamanikya along with Sidharthaka yoga lotion.
排除标准
- •Patients with severe systemic disorders.
- •Uncontrolled hypertension, Cardiac diseases, Diabetes mellitus.
- •Pregnant Women and lactating mothers.
- •Severe cases of Psoriasis Patients who are under the Ayurvedic treatment with other formulations.
结局指标
主要结局
1. To assess the levels of mercury and arsenic levels in serum and urine samples of Kitibhakushtha patients during and post-intervention of study drugs
时间窗: baseline and after 12 weeks
次要结局
- To evaluate the safety of Arogyavardhini Vati & Rasamanikya along with Sidharthaka Yoga(Lotion based on kidney injury biomarkers)
研究者
Dr Jha Mohan Yogendra
All India Institue of Ayurveda