An open randomized clinical control study to assess the effect of Kala basti krama with Rasnadi Niruha and Anuvasana in Prameha poorvaroopavastha wsr to prediabetic condition
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Improvement in subjective and objective criteria of poorvaroopavastha of Prameha
研究概览
简要总结
Prediabetes is a condition in which blood sugar levels are higher than normal but not high enough to be caused diabetes.
It is one of the lifestyle disorders which is caused due to improper food , lifestyle and stress.
If patient is not treated at prediabetes stage, it may cause diabetes mellitus in future. Diabetes mellitus affects all systems of the body and can cause further complications.
So it is very important that patient should be assessed and treated in Prediabetes stage.
Ayurveda also believed that any disease should be treated in poorvaroopavastha.
So I have selected this disease.
Kala Basti krama with Rasnadi Niruha and Anuvasana have been selected because it has all tikta, katu rasatmak , rooksha drugs which will act on kapha dosha and prameha vyadhi.
The study is divided into 2 arms with 32 participants each.
Intervention arm - Kala Basti krama with Rasnadi Niruha and Anuvasana will be given for a period of 15 days.
Control arm - Panchatikta Panchaprasrutiki Basti will be given for a period of 15 days.
Participants will be selected as per inclusion criteria.
Computer based Randomization process will be used.
Patients will be assessed on Day 1, Day 15 and Day 45 of study.
Patients will be assessed as per subjective and objective criteria.
Objective criteria- Fasting blood sugar levels, Post Prandial Blood Glucose levels.
Subjective criteria - Signs and Symptoms of poorvarropavastha of prameha
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with fasting blood glucose levels between 110-125mg/dl 2)Patients with post prandial blood glucose levels between 140-200 mg/dl 3)Patients with grade 0-2 of any 3 of the following signs and symptoms of poorvaroopavastha of prameha a)Swedadhikya b)Shayyasana swapnasukham c)Karapadadaha or Karapadasuptata d)Atitrushna e)Angagauravta.
排除标准
- •Patients with presenting complications of diabetes like diabetic nephropathy, retinopathy.
- •Patients with anorectal disorders like piles, fissure, fistula.
- •Patients with renal disease.
- •Patients with hyperuricemia 5)Patients with any form of malignancy.
- •Pregnant and lactating mothers.
结局指标
主要结局
Improvement in subjective and objective criteria of poorvaroopavastha of Prameha
时间窗: Day 45. | Follow up on Day 1 . Day 15 and Day 45
次要结局
- Imporovement in fasting blood glucose levels.(Day 45)
- Improvement in post prandial blood glucose levels.(Day 45)
- Improvement in grades of signs and symptoms of poorvaroopavastha of prameha-(Swedadhikya, Shayyasana swapnasukha, Karapada daha or suptata, Atitrushna and Angagauravta)
研究者
Dr Neeraja Suresh Iyer
R.A Podar Ayurvedic Medical College