Bauhinia Forficata in Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: Placebo; Drug: B. forficata

• Registration Number: NCT02760017
• Lead Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-09
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	capsules containing placebo for B forticata
B. forficata	B. forficata	capsules of B. forficata containing 200 mg of plant extracts

Primary Outcome Measures

Name	Time	Method
glycated hemoglobin levels	4 months
fasting glucose levels	4 months

Secondary Outcome Measures

Name	Time	Method
Plasma inflammatory parameters levels	4 months	Interleukin-6 and c-reactive protein levels
Plasma oxidative stress parameters levels	4 months	Advanded glycation end-products, protein carbonyl and lipid peroxidation levels
Plasma endothelin-1 levels	4 months

Trial Locations

Locations (1)

Universidade do Extremo Sul Catarinense; 🇧🇷 Criciuma, Santa Catarina, Brazil