Bauhinia Forficata in Diabetic Patients

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760017
• Other study ID #: 401336/2013-1
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• B. forficata

• Placebo

Locations

Country	Name	City	State
Brazil	Universidade do Extremo Sul Catarinense	Criciuma	Santa Catarina

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin levels		4 months
Primary	fasting glucose levels		4 months
Secondary	Plasma inflammatory parameters levels	Interleukin-6 and c-reactive protein levels	4 months
Secondary	Plasma oxidative stress parameters levels	Advanded glycation end-products, protein carbonyl and lipid peroxidation levels	4 months
Secondary	Plasma endothelin-1 levels		4 months