Clinical trial NCT02760017: Bauhinia Forficata in Diabetic Patients
Official title: Evaluation of Clinical Efficacy Capsules Containing Standardized Extract of Bauhinia Forficata (Pata- De-vaca) in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: glycated hemoglobin levels
timeFrame: 4 months
measure: fasting glucose levels
timeFrame: 4 months
Secondary outcomes:
measure: Plasma inflammatory parameters levels
timeFrame: 4 months
measure: Plasma oxidative stress parameters levels
timeFrame: 4 months
measure: Plasma endothelin-1 levels
timeFrame: 4 months
Other outcomes:
Locations:
city: Criciuma
country: Brazil
facility: Universidade do Extremo Sul Catarinense
state: Santa Catarina
Study officials:
References: