Study the effect of Panchtikta niruh basti in the management of sthool pramehi withspecial reference to diabetes mellitus (type-2) - Randomised controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To asses hypoglycemic action of intervention group in Prediabetics by taking into consideration of these standard markers i.e.
研究概览
简要总结
Study summary -
This clinical trial is a controlled trial for MD dessertation under MUHS University .
total duration of trial - 3 years
Title name - Study the effect of Panchtikta niruh basti in the management of sthool pramehi with
special reference to diabetes mellitus (type-2) - Randomised controlled trial.
Intervention group - Panchtikta Niruh basti (panchkarma chikitsa)
control group - lifestyle modification and Diet ( as per clinically proven proforma and charts)
Groups
Group A - Intervention ( panchtikta Niruh basti kram - 8 days * 2 sittings ) + lifestyle modifications and Diet chart .
Group B - Only lifestyle modifications and Diet chart .
Duration - Three months for each patient.
Name of student - Dr. Tirth Mihirbhai Shah
Name of Guide - Dr. Kalpana Gholap- Dhomse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •RECENTLY DIAGNOSED CASE OF TYPE -2 DM WITH 1.Blood Sugar Levels Fasting 100 mg/dl – 126 mg/dl AND/OR Blood Sugar Levels PostPrandial 140 mg/dl -199 mg/dl. 2.Glycosylated hemoglobin i.e. HbA1C.
- •5.7 – 6.4 3.BMI > 25 ( overweight) [19]] 4.Gender: Male & Female both 5.Age.
- •30 to 60 years.
排除标准
- •TYPE-1 Diabetes Mellitus (IDDM) or patients who are currently on Insulin or any Oral Hypoglycemic Agents.
- •k/c/o ketoacidosis, diabetic coma, diabetic nephropathy , Uncontrolled Hypertension ,gangrene.
结局指标
主要结局
To asses hypoglycemic action of intervention group in Prediabetics by taking into consideration of these standard markers i.e.
时间窗: 1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
1.BSL-Fasting & Postprandial
时间窗: 1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
2. HBA1C
时间窗: 1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
2)Compare the effect of panchtikta Niruh basti along with lifestyle modifications and specific diet in prediabetics.
时间窗: 1) BSL - FF AND PP ON | Baseline , 1 month and 3 months. | 2)HBA1C on baseline and after 3 MONTHS .
次要结局
- To assess the effect of Panchtikta Niruh Basti in improving BMI & Waist circumference .(DAY 0 AND DAY 90)