A randomized double blinded placebo controlled comparative clinical study to evaluate the safety and efficacy of probiotics in the management of type 2 diabetic patients.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- 1. Fasting and post prandial blood sugar levels. (Time points: Day
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 100 participants will be randomized into two groups. Dosing will be done twice daily orally for 90 days. Subjects will be asked to visit facility for their follow up on day 30, day 60 and day 90 and any other additional visits if needed.
Primary Outcome
- Fasting and post prandial blood sugar levels. (Time points: Day
0, Day 30, Day 60 and Day 90)
-
HbA1c levels (Time points: Day 0 and Day 90)
-
Overall global status of improvement and quality of life (Time
points: Day 0 and Day 90)
- Change in the anthropometrics and blood pressure measurements
from baseline to post study (Time points: Day 0 and Day 90)
- Change in lipid profile from baseline to post study (Time points:
Day 0 and Day 90)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing and able to provide written informed consent prior to performing study procedures.
- •Type II diabetic patients between the age of 18-65 years.
- •Males or females; females must be non-pregnant / non-lactating and practicing adequate birth control measures if not menopausal.
- •Participants with HbA1c 6.
- •Patient should not have participated in any other clinical trial during the past 3 months.
排除标准
- •Type 1 diabetes mellitus and pre diabetics.
- •Concomitant gastrointestinal disorders (i.e., irritable bowel syndrome, inflammatory bowel disease and coeliac disease)
- •Recent use (within the previous 4 weeks) of antibiotics and dietary supplements (fish oil, probiotics, prebiotics, multivitamins, minerals, nutraceuticals and herbal preparations)
- •K/C/o cardiovascular or renal complications.
- •Patients who are on immunomodulatory or immunosuppressants for any other illness.
- •History of allergy to probiotics.
结局指标
主要结局
1. Fasting and post prandial blood sugar levels. (Time points: Day
时间窗: Day 0, Day 30, Day 60 and Day 90
0, Day 30, Day 60 and Day 90)
时间窗: Day 0, Day 30, Day 60 and Day 90
2. HbA1c levels (Time points: Day 0 and Day 90)
时间窗: Day 0, Day 30, Day 60 and Day 90
3. Overall global status of improvement and quality of life (Time
时间窗: Day 0, Day 30, Day 60 and Day 90
points: Day 0 and Day 90)
时间窗: Day 0, Day 30, Day 60 and Day 90
4. Change in the anthropometrics and blood pressure measurements
时间窗: Day 0, Day 30, Day 60 and Day 90
from baseline to post study (Time points: Day 0 and Day 90)
时间窗: Day 0, Day 30, Day 60 and Day 90
5. Change in lipid profile from baseline to post study (Time points:
时间窗: Day 0, Day 30, Day 60 and Day 90
Day 0 and Day 90)
时间窗: Day 0, Day 30, Day 60 and Day 90
次要结局
- â— Each patient will undergo a complete physical examination, blood(sugar level assessment before enrolment in the study.)
研究者
Dr M Sakthi Balan MD
Ki3 Private Limited