Bauhinia Forficata in Diabetic Patients

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: B. forficata
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>capsules containing placebo for B forticata | Drug: Placebo<br> <br> |
| Experimental: B. forficata<br>capsules of B. forficata containing 200 mg of plant extracts | Drug: B. forficata<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin levels |  | 4 months | 
| fasting glucose levels |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma inflammatory parameters levels | Interleukin-6 and c-reactive protein levels | 4 months | 
| Plasma oxidative stress parameters levels | Advanded glycation end-products, protein carbonyl and lipid peroxidation levels | 4 months | 
| Plasma endothelin-1 levels |  | 4 months |