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临床试验/NCT02760017
NCT02760017已完成不适用

Evaluation of Clinical Efficacy Capsules Containing Standardized Extract of Bauhinia Forficata (Pata- De-vaca) in Diabetic Patients

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
glycated hemoglobin levels

研究概览

简要总结

Among the plants most used in folk medicine for the treatment of diabetes are the species of the genus Bauhinia (Fabaceae), popularly known in Brazil as "pata-de-vaca". Of these, Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due to this fact it is included in the Medicinal Plants List of the Brazilian Public Health System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its chemical composition and its pharmacological potential. From the chemical point of view the main components identified in hydro alcoholic extract of the leaves are O-glycosylated derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity of B. forficata in clinical level was performed in only two studies, both with few patients, and questionable methodological quality that used tea as a pharmaceutical form, a fact that allows us to question the validity of data considering the risks of no dose reproducibility ingested by patients during the study. Thus the investigators here intend to determine the effects of a standardized extract of B. forficata in the control of patients with diabetes mellitus

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type II diabetic patients
  • Using oral antidiabetic treatment for at least 3 months
  • Glycated hemoglobin levels > 7.5% or
  • Fasting glucose levels >=100mg/dl

排除标准

  • Type 1 diabetes patients
  • History of cancer under treatment
  • Major cardiovascular event during the last 90 days (eg. stroke, myocardial infarction)
  • Pregnancy
  • Lactation
  • Serious diseases presenting limited short-term prognosis (eg stage IV COPD end-stage heart failure)
  • Child B or C cirrhotic patients
  • Patients with chronic renal failure on dialysis

研究组 & 干预措施

placebo

Placebo Comparator

capsules containing placebo for B forticata

干预措施: Placebo (Drug)

B. forficata

Experimental

capsules of B. forficata containing 200 mg of plant extracts

干预措施: B. forficata (Drug)

结局指标

主要结局

glycated hemoglobin levels

时间窗: 4 months

fasting glucose levels

时间窗: 4 months

次要结局

  • Plasma inflammatory parameters levels(4 months)
  • Plasma oxidative stress parameters levels(4 months)
  • Plasma endothelin-1 levels(4 months)

研究者

发起方
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
申办方类型
Other
责任方
Principal Investigator
主要研究者

Felipe Dal Pizzol

MD, PhD

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

研究点 (1)

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