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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145534
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : November 9, 2011
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of Paraíba

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Drug: glibenclamide Other: medicinal plant infusion Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145534


Locations
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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
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Study Chair: Fabio C Sampaio, PhD Federal University fo Paraiba
More Information
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Additional Information:

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Responsible Party: Rosana Araújo Rosendo, Federal University of Paraiba
ClinicalTrials.gov Identifier: NCT01145534    
Other Study ID Numbers: UFPB-0346
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: August 2008
Keywords provided by Federal University of Paraíba:
diabetes,
medicinal plants,
glucose
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs