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临床试验/NCT03437902
NCT03437902已完成2 期

Evaluation of the Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年2月24日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
53
试验地点
1
主要终点
Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients

研究概览

简要总结

The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients' age 35 years or older having type 2 diabetes mellitus.
  • Patients taking oral diabetic medications (Sulfonylurea) not taking Insulin.
  • Able to understand and willing to sign a written informed consent document

排除标准

  • • Pregnant and breast feeding females
  • use of vitamin supplements containing vitamin C or other antioxidants.
  • patients with renal or hepatic failure.
  • patients taking insulin as antidiabetic treatment

研究组 & 干预措施

Control group

No Intervention

patients will receive their usual antidiabetic treatment only for 8 weeks.

Rutin C group

Experimental

patients will receive Rutin 60 mg in combination with vitamin C 160 mg three times daily in addition to usual antidiabetic treatment for 8 weeks..

干预措施: Rutin in combination with Vitamin C (Dietary Supplement)

Vitamin C group

Experimental

patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.

干预措施: Vitamin C (Dietary Supplement)

结局指标

主要结局

Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients

时间窗: Two months

Effect of Rutin and vitamin C combination or vitamin C alone on oxidative stress marker (MDA) and on antioxidant capacity (SOD) in diabetic patients after 8 weeks of treatment.

Insulin resistance in diabetic patients .

时间窗: Two months

Effect of Rutin and vitamin C combination or vitamin C alone on insulin resistance in diabetic patients before i and after treatment for 8 weeks .

Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).

时间窗: Two months

Impact of Rutin and vitamin C combination or vitamin C alone on lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).

次要结局

  • Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .(Two months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sara ramzy ragheb

Assistant Lecturer

Ain Shams University

研究点 (1)

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