Bauhinia Forficata in Diabetic Patients

NCT02760017 | Completed

• 1 other identifier: 401336/2013-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• glycated hemoglobin levels

  4 months

• fasting glucose levels

  4 months

Secondary Outcomes (3)

• Plasma inflammatory parameters levels

  4 months

• Plasma oxidative stress parameters levels

  4 months

• Plasma endothelin-1 levels

  4 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

capsules containing placebo for B forticata

Drug: Placebo

B. forficata

EXPERIMENTAL

capsules of B. forficata containing 200 mg of plant extracts

Drug: B. forficata

Interventions

B. forficata DRUG

B. forficata

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II diabetic patients
• Using oral antidiabetic treatment for at least 3 months
• Glycated hemoglobin levels \> 7.5% or
• Fasting glucose levels \>=100mg/dl

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88801450, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

BR (1)