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Completed

NCT Number: NCT01145534

Evaluation of Cissus Verticillata L. Infusion in Controlling Type 2 Diabetes

The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centro de Especialidades Odontologicas

Patos, Paraíba, 58700-020, Brazil

About this study

Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. In many developing countries, this condition is regarded as major public health problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. As Diabetes progresses, medications are necessary to control glucose levels.

The aim of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been used as potential medication for controlling glucose levels in Diabetes patients. Few studies have explored this effect related to Cissus verticillata L.infusion, though it has been indicated by folk medicine of some Latin American countries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects of 30 up to 80 years of age
  • positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dL)
  • patients that signed the informed consent

Exclusion criteria

  • patients with renal and hepatic disfunction,
  • patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems)
  • pregnant women

Treatment and study plan

glibenclamide

Drug

5 mg as pills, taken daily during the morning for 60 days

Other names: Glibenclamida, Legrand GE

medicinal plant infusion

Other

INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.

Other names: popular plant name: Insulina

Primary outcomes

  1. blood glucose

    Time frame: 60 days

    Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.

Secondary outcomes

  1. Salivary glucose level

    Time frame: 60 days

    The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes.

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 16, 2010
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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