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临床试验/NCT01145534
NCT01145534已完成1 期

Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration

Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
blood glucose

研究概览

简要总结

The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients.

详细描述

Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. In many developing countries, this condition is regarded as major public health problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. As Diabetes progresses, medications are necessary to control glucose levels.

The aim of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been used as potential medication for controlling glucose levels in Diabetes patients. Few studies have explored this effect related to Cissus verticillata L.infusion, though it has been indicated by folk medicine of some Latin American countries.

研究设计

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

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects of 30 up to 80 years of age
  • positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dL)
  • patients that signed the informed consent

排除标准

  • patients with renal and hepatic disfunction,
  • patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems)
  • pregnant women

研究组 & 干预措施

Glibenclamide

Active Comparator

Patients used 5 mg glibenclamide daily for 60 days

干预措施: glibenclamide (Drug)

Experimental

Experimental

Patients ingested the infusion of Cissus verticillata L. prepared as 1 g in 150 mL of hot water for 10 min. This was done daily for 60 days

干预措施: medicinal plant infusion (Other)

结局指标

主要结局

blood glucose

时间窗: 60 days

Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.

次要结局

  • Salivary glucose level(60 days)

研究者

发起方
Federal University of Paraíba
申办方类型
Other

研究点 (1)

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