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

November 8, 2011 updated by: Federal University of Paraíba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraiba
      • Patos, Paraiba, Brazil, 58700-020
        • Centro de Especialidades Odontologicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • popular plant name: Insulina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose
Time Frame: 60 days
Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Chair: Fabio C Sampaio, PhD, Federal University fo Paraiba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPB-0346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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