A Clinical Study to evaluate the effect of combination of Bhumyamalaki ( Phyllanthus niruri) and Kali Maricha ( Piper nigrum) on Madhumeha WSR to Diabetes Mellitus
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To Assess the subjective symptoms like:
研究概览
简要总结
Diabetes Mellitus is a clinical syndrome characterized by hyperglycemia due to absolute or relative deficiency of insulin. It is a leading cause of morbidity and mortality all over the world . The Prevalence of DM in India is currently reported to be around 13-15% and by 2025 it is estimated that approximately 55 million Indians will be Diabetic. The properties of Bhumyamalaki and Kali maricha drug have potential to treat the Madhumeha/DM more efficiently.
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Total patients - 60
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Group - I & II
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Present title- "A Comparative clinical study to evaluate the efficacy of Bhumyamalaki Churna and Kali Maricha Churna on Madhumeha w s r to Diabetes Mellitus".
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Both drugs will be given for 30 days and will be analyzed on the basis of subjective and objective criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who will give written consent.
- •Patient having clinical features of Madhumeha according to Ayurvedic Classics.
- •Patient who are on oral hypoglycemic drugs but still having hyperglycemia.
排除标准
- •Patient who are insulin dependent.
- •Patient below 30 years and high chances of being DM type -
- •Gestational Diabetes Mellitus, Pregnancy.
结局指标
主要结局
To Assess the subjective symptoms like:
时间窗: 1st day | 8th day | 15th day | 30th day
Prabhoota mutrata (polyuria)
时间窗: 1st day | 8th day | 15th day | 30th day
Avila mutrata (Turbid urine)
时间窗: 1st day | 8th day | 15th day | 30th day
Sthulata (Weight gain)
时间窗: 1st day | 8th day | 15th day | 30th day
Shrama ( Fatigue)
时间窗: 1st day | 8th day | 15th day | 30th day
次要结局
- To assess the objective parameter like:(Blood sugar level)