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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145534
• Other study ID #: UFPB-0346
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 15, 2010
• Last updated: November 8, 2011
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2008
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Conselho Nacional de Saude
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Other:
• medicinal plant infusion
INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.

Locations

Country	Name	City	State
Brazil	Centro de Especialidades Odontologicas	Patos	Paraiba

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Paraíba	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose	Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.	60 days	Yes
Secondary	Salivary glucose level	The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes.	60 days	Yes

External Links

•   Official research group for studies related to medicinal plants