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NCT Number: NCT02760017

Bauhinia Forficata in Diabetic Patients

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88801450, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B. forficata

Drug

Placebo

Drug

Primary outcomes

  1. glycated hemoglobin levels

    Time frame: 4 months

  2. fasting glucose levels

    Time frame: 4 months

Secondary outcomes

  1. Plasma inflammatory parameters levels

    Time frame: 4 months

    Interleukin-6 and c-reactive protein levels

  2. Plasma oxidative stress parameters levels

    Time frame: 4 months

    Advanded glycation end-products, protein carbonyl and lipid peroxidation levels

  3. Plasma endothelin-1 levels

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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