Nephroprotective Effects of Fig (Ficus Carica L.) Leaf Supplementation in Grade II Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
Diabetic nephropathy is the result of diabetes complications. Excessive blood glucose levels affect several organs which include liver, heart, and kidneys.The aim of this study is to use the nephroprotective and metabolic effects of fig (Ficus carica L.) leaf supplementation with a low glycemic index diet in grade-II chronic kidney disease patients.
详细描述
A pre and post treatment study that evaluated 60 patients (35-65 years old) diagnosed with diabetes and stage 2 chronic kidney disease. Purposive sampling was used to include patients that fit the criteria. The 60 patients selected were randomly divided among two groups: control group and intervention group, each group with 30 patients. Control group patients were given green tea and intervention group patients were given fig leaf tea along with a low glycemic index diet. The tea for both groups was assigned to drink twice a day. The period of this research is 8 weeks. At four weeks , the participants were asked for their feedback. Pre- and post-results were assessed and monitored
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People within the age range of 35-65 years old adults (both genders)
- •Individuals diagnosed with Type 2 diabetes with an HbA1c level between 7-13%
- •Diabetics that consume oral hypoglycemic medication
- •Participants must have a BMI between 25kg/m2 and 39.9kg/m2
排除标准
- •Pregnant and lactating women
- •Individuals that use insulin therapy apart from medication
- •Severe complications like diabetic ketoacidosis
- •Individuals with highly restricted diets
- •Allergic to latex or figs.
结局指标
主要结局
Body Mass Index
时间窗: 8 weeks
Body mass index (BMI) is a universally utilized anthropometric screening tool that is used to assess a person's health by evaluating their obesity and nutritional status, applies for both males and females. For body mass index weight in kg and height in meters squared, were used to calculate changes in body size.
Fasting blood glucose (FBG)
时间窗: 8 weeks
Fasting blood glucose (FBG) is a simple test that measures a person's blood sugar level after fasting for approximately 8-12 hours. This test determines the amount of glucose present on an empty stomach to understand the baseline of glucose levels. A glucometer is used to measure FBG. The unit for FBG is mg/dL. For this study the range to determine stage 2 diabetic kidney damage is approximately 120 - 300 mg/dL.
Lipid profile
时间窗: 8 weeks
Lipid profile is a key blood-based biomarker that measures the amount of lipid present in the blood of a person. The key components of lipid profile we will use are triglycerides, total cholesterol, low density lipoprotein (LDL), and high density lipo-protein (HDL). These components are used to detect any unnecessary amount of lipids present in the blood for early detection of health issues. Triglycerides are the storage form of lipid. Total cholesterol is the overall amount of lipid components. LDL also known as "bad" cholesterol accumulates in blood causing problems in bloodstream. HDL also known as "good" cholesterol reduces amounts of LDL cholesterol in blood. The unit used is mg/dL (L. Wang et al., 2022). In this study the ranges used to determine stage 2 diabetic kidney damage are: triglycerides (150 - 290mg/dl), total cholesterol (160 - 300 mg/dl), LDL (130 - 190 mg/dl), and HDL (20 - 50 mg/dl).
Renal function tests
时间窗: 8 weeks
Renal function tests (RFT) take place to evaluate the functionality of kidneys and if they properly filter waste. Blood and urine samples are taken, and serum creatinine and blood urea nitrogen (BUN) are tests that detect possible kidney damage or disease. For diabetics diagnosis of kidney damage as early as possible is essential for treatment (Gounden, Bhatt, \& Jialal, 2024). In this study the ranges used to determine Stage 2 diabetic kidney damage are: serum creatinine (1.05 - 2.0 mg/dl), and blood urea nitrogen (20 - 46 mg/dl).
次要结局
未报告次要终点
研究者
Maria Aslam
Clinical Head
University of Lahore