Diabetes
Conditions
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
Interventions
DRUGB. forficata
DRUGPlacebo
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycated hemoglobin levels | 4 months |
| fasting glucose levels | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Brazil
Outcome results
None listed