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CompletedNCT02760017Updated Jun 12, 2018

Bauhinia Forficata in Diabetic Patients

An interventional study of B. forficata and Placebo in Diabetes, sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude. Completed at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    placebo

    capsules containing placebo for B forticata

    Drug: Placebo

  • Experimental
    B. forficata

    capsules of B. forficata containing 200 mg of plant extracts

    Drug: B. forficata

Interventions

  • DrugB. forficata
  • DrugPlacebo
06

What researchers measure

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

    Interleukin-6 and c-reactive protein levels

    Time frame: 4 months

  2. Plasma oxidative stress parameters levels

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

    Time frame: 4 months

  3. Plasma endothelin-1 levels

    Time frame: 4 months

07

Study locations

1 site
  • Universidade do Extremo Sul Catarinense
    Criciuma, Santa Catarina 88801450, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02760017
Lead sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Felipe Dal Pizzol (MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude) — Principal investigator
First posted
May 3, 2016
Start date
Apr 2016
Primary completion
Aug 2017
Completion
Sep 2017
Last update
Jun 12, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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