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Bauhinia Forficata in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT02760017
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

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

Condition or disease Intervention/treatment Phase
Diabetes Drug: B. forficata Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Clinical Efficacy Capsules Containing Standardized Extract of Bauhinia Forficata (Pata- De-vaca) in Diabetic Patients
Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. glycated hemoglobin levels [ Time Frame: 4 months ]
  2. fasting glucose levels [ Time Frame: 4 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760017


Locations
Brazil
Universidade do Extremo Sul Catarinense
Criciuma, Santa Catarina, Brazil, 88801450
Sponsors and Collaborators
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
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
ClinicalTrials.gov Identifier: NCT02760017     History of Changes
Other Study ID Numbers: 401336/2013-1
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018