NCT01145534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
Last Updated

November 9, 2011

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

June 15, 2010

Last Update Submit

November 8, 2011

Conditions

Diabetes

Keywords

diabetes,medicinal plants,glucose

Outcome Measures

Primary Outcomes (1)

  • blood glucose

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

    60 days

Secondary Outcomes (1)

  • Salivary glucose level

    60 days

Study Arms (2)

Glibenclamide

ACTIVE COMPARATOR

Patients used 5 mg glibenclamide daily for 60 days

Drug: glibenclamide

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

Interventions

glibenclamideDRUG

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

Also known as: Glibenclamida, Legrand GE
Glibenclamide
medicinal plant infusionOTHER

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

Also known as: popular plant name: Insulina
Experimental

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Especialidades Odontologicas

Patos, Paraíba, 58700-020, Brazil

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Fabio C Sampaio, PhD

    Federal University fo Paraiba

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

November 9, 2011

Record last verified: 2008-08

Locations

BR(1)