Bauhinia Forficata in Diabetic Patients

Last updated: June 9, 2018
Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Overall Status: Completed

Phase

N/A

Condition

Diabetic Neuropathy

Diabetic Macular Edema

Diabetic Vitreous Hemorrhage

Treatment

N/A

Clinical Study ID

NCT02760017
401336/2013-1
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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-stageheart failure)

  • Child B or C cirrhotic patients

  • Patients with chronic renal failure on dialysis

Study Design

Total Participants: 80
Study Start date:
April 01, 2016
Estimated Completion Date:
September 30, 2017

Connect with a study center

  • Universidade do Extremo Sul Catarinense

    Criciuma, Santa Catarina 88801450
    Brazil

    Site Not Available

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