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

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Other: medicinal plant infusion; Drug: glibenclamide

• Registration Number: NCT01145534
• Lead Sponsor: Federal University of Paraíba

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 Timeline

• Status Verified: 2008-08
• Study Start: 2009-01
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	medicinal plant infusion	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
Glibenclamide	glibenclamide	Patients used 5 mg glibenclamide daily for 60 days

Primary Outcome Measures

Name	Time	Method
blood glucose	60 days	Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.

Secondary Outcome Measures

Name	Time	Method
Salivary glucose level	60 days	The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes.

Trial Locations

Locations (1)

Centro de Especialidades Odontologicas; 🇧🇷 Patos, Paraiba, Brazil