A randomized controlled clinical study to evaluate the effect of Masura yusha as Pathya in Prediabetes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of treatment will be assessed on the basis
研究概览
简要总结
A minimum of 60 patients fulfilling the inclusion, exclusion and diagnostic criteria of Pre-diabetes irrespective of gender, religion, occupation, marital status and socio-economic status will be selected from OPD and IPD of Alvas ayurveda medical college and hospital and randomly divided into two equal groups, group A and group B.
GROUP A: 30 patients of group A will be advised to follow Dietary Interventions for 15 days.
GROUP B: 30 patients of group B will be given with 150ml of Masura Yusha once in a day at night time and advised to follow Dietary Interventions for 15 days.
Patients will be assessed on 0th day and on 15th, 30th, 45th day. Patient will be assessed with subjective and objective parameters formulated and the data obtained will be recorded and statistically analysed.
The study will be published in a reputed journal after the completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fasting Plasma Glucose value between 100mg/dl – 125mg/dl
- •2hr Plasma Glucose or OGTT value between 140mg/dl – 199mg/dl
- •Patients with or without following features of Pre-diabetes: -Increased thirst -Frequent desire to urinate.
排除标准
- •FPG value ≥ 126mg/dl
- •OGTT value ≥ 200mg/dl
- •Patients under Hypoglycemic drugs
- •Gestational diabetes
- •Patient with chronic systemic diseases.
结局指标
主要结局
Effect of treatment will be assessed on the basis
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
of gradation of both subjective and objective
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
parameters before and after treatment.
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
Subjective parameter:
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
• Increased thirst
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
• Frequent desire to
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
urinate
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
Scoring will be given to each parameter and will be assessed before and after the intervention.
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
Objective parameter:
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
• FBS
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
• PPBS
时间窗: Study duration:45 days | 15 days of intervention and follow up on 30th and 45th day. | OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
次要结局
- Effect of treatment will be assessed on the basis(of FBS & PPBS before & after the treatment, 30th day & 45th day.)
研究者
DR LIKHITHA H K
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL