Evaluation of Clinical Efficacy Capsules Containing Standardized Extract of Bauhinia Forficata (Pata- De-vaca) in Diabetic Patients
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
- 否
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
capsules containing placebo for B forticata
干预措施: Placebo (Drug)
B. forficata
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
Felipe Dal Pizzol
MD, PhD
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
