Clinical efficacy of capsules containing standardized extract of Bauhinia forficata Link (pata-de-vaca) as adjuvant treatment in type 2 diabetes patients: A randomized, double blind clinical trial

J Ethnopharmacol. 2022 Jan 10:282:114616. doi: 10.1016/j.jep.2021.114616. Epub 2021 Sep 7.

Abstract

Ethnopharmacological relevance: Bauhinia forficata Link, is a Brazilian native plant and popularly known as pata-de-vaca ("paw-of-cow"). The tea prepared with their leaves has been extensively used in the Brazilian traditional practices for the diabetes treatment. The aim of the present study was to investigate the effect of capsules containing granules of a standardized extract of B. forficata leaves as adjuvant treatment on the glycemic control of patients with type-2 diabetes melitus.

Materials and methods: A double-blind, randomized clinical trial using capsules containing granules prepared by wet granulation of a standardized extract from B. forficata leaves as adjuvant treatment, was conducted. 92 patients aged 18-75 years from an outpatient clinic with type-2 diabetes were randomly assigned by a simple randomization scheme, in a 1:1 ratio to receive capsules of B. forficata or placebo for four months. The capsules used contain 300 mg of standardized extract from B. forficata leaves, yielding 2% of total flavonoid content per capsule. Primary outcome was glycated hemoglobin levels and fasting plasma glucose at 4 months. Possible harms were also determined.

Results: The findings showed that at 4 months, the mean fasting plasma glucose levels and glycated hemoglobin were both significantly lower in the B. forficata group than in the placebo group.

Conclusion: The present study suggests that the adjunctive use of capsules containing standardized extract of B. forficata can add to regular oral anti-diabetics in the metabolic and inflammatory control of type-2 diabetes patients.

Keywords: Bauhinia forficata; Double-blind clinical trial; HbA1c; Pata-de-vaca; Type-2 diabetes.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Bauhinia / chemistry*
  • Blood Glucose / drug effects
  • Brazil
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Hypoglycemic Agents / chemistry
  • Hypoglycemic Agents / therapeutic use
  • Male
  • Middle Aged
  • Phytotherapy*
  • Plant Extracts / chemistry
  • Plant Extracts / therapeutic use*
  • Plant Leaves / chemistry*
  • Young Adult

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Plant Extracts