A controlled clinical study to evaluate the effect of Ketaki mula niruha basti and madhutailika basti in madhumeha with special reference to diabetes mellitus-2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Polyurea
研究概览
简要总结
Prameha is a tridoshaja vyadhi,4produced due to over indulgence in heavy, richly nutritiousfood, day sleep, lack of cleanliness, exercises and other sedentary habits.5 Madhumeha is oneamong the types of prameha.6It is one among astamahagada.7,8 It is a anushangi vikara.9Diabetes mellitus-2 can be equated with madhumeha as both have similar etiologies, symptomsand complications. Global prevalence of Diabetes mellitus is estimated to be around 374 million in2017 and projected to increase to 587 million adults by 2045 equalling 8.4% of total population.It is more prevalent in low and middle income countries.10 Its incidence is also increasing at analarming rate. There were 65 million prevalent cases of diabetes in India in 2016.11 It Hasbecome of utmost importance to find ways to combat this disease. Ketaki is one among wide variety of the drugs which has been described in thetreatment of meha.12 It is easily available, cost effective. Traditionally the roots of ketakibelieved to have antidiabetic, antidiuretic, cardiotonic and aphrodisiac properties.13 Madhutailika basti can be administered to the person who desires to take niruhabasti.14 It is one among the bastis told by samhita in the treatment of meha.15A study has beenconducted on the effect of madhutailika basti in management of madhumeha by DoddabasayyaS Swamy and it found statistically significant result, hence this study, “A controlled clinicalstudy to evaluate the effect of Ketakimoola niruha basti and Madhutailika basti inmadhumeha w.s.r.t Diabetes mellitus-2â€, aims to assess the madhumehahara karma ofKethakimoola niruha basti and Madhutailika basti, and to find better treatment among these.
HYPOTHESIS
H0: There is no difference in the effect of Ketaki niruha basti and Madhutailika basti inmadhumeha.
H1: There is difference between effect of Ketaki Moola niruha basti and Madhutailika basti inmadhumeha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Post prandial blood sugar (ppbs) level between 160-280 mg/dL.
- •HbA1C level between 6.5%-11%.
排除标准
- •1.Subjects with type 2 diabetes mellitus who are insulin dependent.
- •2.Subjects who are diagnosed to have complications like diabetic foot, diabetic retinopathy and other secondary complications.
- •4.Pregnant and lactating woman.
结局指标
主要结局
Polyurea
时间窗: 25 days
Polyphagia
时间窗: 25 days
Polydipsia
时间窗: 25 days
次要结局
- Fasting blood sugar(25 Days)
- Post prandial blood sugar(25 days)