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

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of Paraíba
ClinicalTrials.gov Identifier:
NCT01145534
First received: June 15, 2010
Last updated: November 8, 2011
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: glibenclamide
Other: medicinal plant infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration

Resource links provided by NLM:


Further study details as provided by Federal University of Paraíba:

Primary Outcome Measures:
  • blood glucose [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.


Secondary Outcome Measures:
  • Salivary glucose level [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes.


Enrollment: 15
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glibenclamide
Patients used 5 mg glibenclamide daily for 60 days
Drug: glibenclamide
5 mg as pills, taken daily during the morning for 60 days
Other Name: Glibenclamida, Legrand GE
Experimental: Experimental
Patients ingested the infusion of Cissus verticillata L. prepared as 1 g in 150 mL of hot water for 10 min. This was done daily for 60 days
Other: medicinal plant infusion
INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.
Other Name: popular plant name: Insulina

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145534

Locations
Brazil
Centro de Especialidades Odontologicas
Patos, Paraiba, Brazil, 58700-020
Sponsors and Collaborators
Federal University of Paraíba
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Chair: Fabio C Sampaio, PhD Federal University fo Paraiba
  More Information

Additional Information:
No publications provided

Responsible Party: Rosana Araújo Rosendo, Federal University of Paraiba
ClinicalTrials.gov Identifier: NCT01145534     History of Changes
Other Study ID Numbers: UFPB-0346
Study First Received: June 15, 2010
Last Updated: November 8, 2011
Health Authority: Brazil: Conselho Nacional de Saude

Keywords provided by Federal University of Paraíba:
diabetes,
medicinal plants,
glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014