CTRI/2023/09/058064尚未招募3 期
A randomised controlled clinical trial to evaluate the effect of Nishatriphala yoga on HbA1c level in the management of Madhumeha w.s.r. to Diabetes Mellitus
Dr Vijaylaxmi B Hiremath1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of trail drug over the classical symptoms of Madhumeha and HbA1c level
研究概览
简要总结
- Prameha is one of the eight Mahagada. Madhumeha is one of the types of VatajaPrameha involving Ojas as its Dushya, with cardinal symptoms of Prbhuta and Avila Mutrata, Adhika Kshudha, Adhika Trishna and Dourbalya.
- Madhumeha is corelated with Diabetes Mellitus in contemporary science showing symptoms like polyuria, polydipsia, polyphagia, generalized weakness. It is a metabolic disorder which emerged as an important public health problem globally.
- HbA1c (Glycated haemoglobin) has been a standard test of long-term average blood glucose control. It is universally accepted that higher the HbA1c are associated with greater risk of complication from type II diabetes.
- Hence expected to have effect over glycaemic index and also helping in reducing HbA1c subsequently with reduction in signs and symptoms.
- Nishatriphala Yoga is selected to asses it’s effect on HbA1c in the management of Madhumeha.
- 40 Patients of Madhumeha will be selected, subjects shall be pre-screened. Ayurvedic subjective assement parameters of Madhumeha (Type-2 DM) based on Signs and sympotms like bahumutrata, trishnadhikya, adhika kshudha etc.Objective parameters are assessed by gradings of HbA1c and FBS, PPBS.
- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis of results, conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Subjects with classical sign and symptoms of Madhumeha and Type-2 Diabetes Mellitus.
- •â€¢ HbA1C level more than 6.5%.
- •â€¢ On-going antidiabetic treatment at least 3 weeks.
- •â€¢ Patient willing to sign and give consent.
排除标准
- •â€¢ Patient of IDDM (Type-1 DM), Juvenile Diabetes and gestational diabetes mellitus will be excluded.
- •â€¢ Diabetic Patient with co-morbidities, which are life threatening or interferes with the intervention.
- •â€¢ Pregnant and Lactating mother will be excluded.
结局指标
主要结局
Effect of trail drug over the classical symptoms of Madhumeha and HbA1c level
时间窗: 30 day 60 day 90 day
次要结局
- Assessment of Safety of Drug and Adverse drug reactions(Aggravation of the symptoms of Madhumeha)
研究者
研究点 (1)
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