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临床试验/CTRI/2023/09/057645
CTRI/2023/09/057645尚未招募不适用

The Clinical Study of Prediabetes Patients and Comparative Evaluation of Unani Drugs in its Management

Aligarh Muslim University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Blood sugar fasting

研究概览

简要总结

Prediabetic is new nomenclaturecreated in 2002 by ADA & Dept of Health and Human Services. Prediabetes isa practical & convenient term referring to IFG, IGT or glycated haemoglobin(HbA1C) of 60% to 64% each of which places individual at high risk ofdeveloping diabetes and its complications. TheWorld Health Organization (WHO) in 2006 has recommended the term IntermediateHyperglycemia to describe glycaemic levels between ‘normal’ glucose toleranceand diabetes. The term ‘pre-diabetes’ is discouraged to avoid any stigmaassociated with the word diabetes and the fact that many people do not progressto diabetes as the term implies. This disease is also known as Zalaqal Kulliyah, Dolabiya,Duvariya, Charaqia**Moattasha, Silsil AlBaul, Barkariyyah, *Dawwar.*Accordingto the Unani concept the virtual cause of Ziabetus is the fire like heatin the kidneys where Rutubat in the form of water is absorbed in largeamounts and this cannot be filtered as the kidneys absorb water beyond theircapacity and they are not able to retain the volume as a result of which thekidneys just get rid of the water by pushing it towards the bladder.The QuwateMasika weakens because of the intense heat of the kidneys, the patient isthirsty helplessly consuming water which is passed out through the kidneyimmediately. It is similar to Zalqul Meda wal Ama, in which the foodpasses swiftly through the stomach and intestine lacking proper digestion i.e QuwateDafi’ah isstrong. In this condition patient has excessive thirst and consumes plenty ofwater and passes out all the water consumed without any Istehala (metabolism

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient having fasting blood glucose range 100-125 mg/dl.
  • Patient having 2 hours oral glucose tolerance test level range 140-200 mg/dl.
  • Patient having HbA1C in range of 5.7- 6.4 %.
  • Patient willing to sign the written informed consent.

排除标准

  • Patient below 30 years and above 65 years.
  • Prediabetics suffering from any severe complications.
  • Patient with deranged kidney and liver profile.
  • Pregnant and lactating women.
  • Patient who fail to give consent.
  • Patient who fail to follow up.
  • Mentally retarded person.
  • Patient having uncontrolled hypertension.
  • Patient having any severe systemic illness.

结局指标

主要结局

Blood sugar fasting

时间窗: 0 days, 30 days, 60days, 90days

HbA1C

时间窗: 0 days, 30 days, 60days, 90days

次要结局

  • Blood sugar after 2 hrs oral glucose tolerance test(0 days, 30 days, 60days, 90days)

研究者

申办方类型
Government medical college

研究点 (1)

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