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

This study has been completed.

Sponsor:

Collaborator:

National Council for Scientific and Technological Development, Brazil

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 15, 2010

Last Updated Date

November 8, 2011

Start Date ^ICMJE

January 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01145534 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

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

Other Name: Glibenclamida, Legrand GE
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

Study Arm (s)

Active Comparator: Glibenclamide
Patients used 5 mg glibenclamide daily for 60 days

Intervention: 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

Intervention: Other: medicinal plant infusion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01145534

Other Study ID Numbers ^ICMJE

UFPB-0346

Has Data Monitoring Committee

Yes

Responsible Party

Rosana Araújo Rosendo, Federal University of Paraiba

Study Sponsor ^ICMJE

Federal University of Paraíba

Collaborators ^ICMJE

National Council for Scientific and Technological Development, Brazil

Investigators ^ICMJE

Study Chair:

Fabio C Sampaio, PhD

Federal University fo Paraiba

Information Provided By

Federal University of Paraíba

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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