跳至主要内容
临床试验/CTRI/2023/09/057695
CTRI/2023/09/057695尚未招募2 期

Gene Expression Analysis of the inflammatory markers in pathogenesis of Type-2 Diabetes to identify underlying Molecular mechanisms and Biomarkers and its relation to clinical phenotyping of Unani Philosophy

Central Council for Research in Unani Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Reduction in Blood sugar values

研究概览

简要总结

Patients and controls fullfilling the inclusion and exclusion criteria will be recruited for the study.

Aftertemperament assessment 5 ml of blood will be collected from each subject out ofwhom 2ml will be taken in Paxgene tubes for conducting gene expression studiesand 3ml in plain tubes for conducting ELISA test.

Clinical assessment will be carried out every 15 days during the treatment period.Fasting and Post Prandial Blood Sugar will be measured every 15 days till thefinal follow up.

HbA1C and safety profiles will be measured at the baseline and the finalfollow-up (LFT, RFT, Hemogram & Urine Exam).

Qurs-e-Ziabeties Khaas is administered 2BD daily up to 4 months.

The data thus collected is assessed after the completion of the study.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • The patients diagnosed with Type II diabetes, and having a Fasting Blood Sugar of 126 – 175mg/ 100ml and Post Prandial Blood Sugar of 200-250mg/100ml and HbA1C above 6.
  • 8 and Subjects without diabetes for controls.

排除标准

  • Exclusion criteria for patients and controls:- The Subjects who are unwilling to give the blood sample.
  • Pregnant women, lactating women, cancer patients and mentally disorder people.

结局指标

主要结局

Reduction in Blood sugar values

时间窗: 0, 15, 30, 45,60, 75, 90, 105, 120 days

次要结局

  • understanding of Type II diabetes progression & management in relation to Unani philosophy of medicine.(4 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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