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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: glibenclamide
* Other: medicinal plant infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glibenclamide<br>Patients used 5 mg glibenclamide daily for 60 days | Drug: glibenclamide<br>* 5 mg as pills, taken daily during the morning for 60 days<br>* Other names: Glibenclamida, Legrand GE;|
| Experimental: Experimental<br>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<br>* INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.<br>* Other names: popular plant name: Insulina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose | 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 | The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes,, medicinal plants,, glucose