Bauhinia Forficata in Diabetic Patients

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

Status: Completed

Conditions: Diabetes

Treatments: Drug: B. forficata; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02760017

401336/2013-1

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

capsules containing placebo for B forticata

Treatment:

Drug: Placebo

B. forficata

Experimental group

Description:

capsules of B. forficata containing 200 mg of plant extracts

Treatment:

Drug: B. forficata