A clinical study to evaluate the efficacy of bilvadi gutika in blood eosinophilia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduce in absolute eosinophil counts
研究概览
简要总结
this clinical study is about intervention of an ayurvedic formulation called bilvadi gutika in allergic conditions as per the ayurvedic classical reference in order to check the reduce in absolute eosinophil count in the cases of blood eosinophilia. the aim is to study the effect of bilvadi gutika in blood eosinophilia. it is a single arm clinical study with minimum of 30 subjects fulfilling the diagnostic and inclusion criteria, such as the subject with a history of any allergy since 1 year, diagnosis cases of allergy, raised total eosinophil count and raised absolute eosinophil count. subjects will be included between 16 to 60 years of age irrespective of gender. the subject will be administered bilvadi gutika in the dosage of 500mg 2 tablets thrice daily with hot water for 4 weeks. post trial follow up period is 4 weeks. total duration of study is 8 weeks. the observation will be done initially on 1st day before the treatment after 28th day and after 56th day. the effect of treatment will be assessed on the basis of gradation for both subjective and objective parameter before and after the treatment.
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
- 16.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •patient suffering from allergic asthma, allergic cough and allergic skin manifestation since 1 year.
- •diagnosed cases of allergy with not more than 1 year.
- •raised total and absolute eosinophil counts.
- •patient with who have taken anthelminthic drugs at least 3-4 months before.
排除标准
- •patient suffering from psychological disorders, pregnant and lactating women.
- •patient suffering from other systemic diseases or other skin diseases that interfere in prognosis and treatment of disease.
- •patient suffering from fatal diseases like carcinoma of lungs and immunocompromised cases.
结局指标
主要结局
Reduce in absolute eosinophil counts
时间窗: Reduce in absolute eosinophil counts
次要结局
- reduction in subjective parameter.(reduction in symptoms & signs)
研究者
Dr Raghavendra Swamy P
Alvas ayurveda medical collage and hospital
