Diabetes Mellitus
Conditions
Interventions
This is a double-blind, randomized, controlled clinical trial with two arms. Experimental group: 80 diabetic patients will receive capsules containing powdered plant material of Scoparia dulcis (900 m
B01.875.800.575.912.250.583.700.850
Sponsors
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Universidade de Ribeirão Preto
Eligibility
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Have type-2 diabetes mellitus based on the World Health Organization criteria for at least 3 months; Poor disease control (glycosylated hemoglobin of 7-12%); regular use of antidiabetic medicines, stable doses; Age between 12 and 60 years; body-mass index < 40 kg/m2; able to swallow capsules; can read
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus or other specific form of diabetes; Positive test for diabetes-related autoantibodies; Monogenic diabetes; Severe diseases of the digestive system; Stressful conditions (ketoacidosis, coma, severe infection, hospital admission, or surgery) with 3 months; pregnancy or breastfeeding; allergy to S. dulcis or Plantaginaceae family; Liver failure; Chronic kidney disease stage 3g or more; Mental disease; abusive alcohol use; drug addiction; triglycerides > 400 mg/dL or low-density lipoprotein cholesterol > 180 mg/dL; patient request
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected: We expect to find a decrease in glycosilated hemoglobin (HbA1c), determined by high-performance liquid chromatography (HPLC), of at least 0.5 percent points after 6 months compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| We do not expect secondary outcomes. | — |
Countries
Brazil
Contacts
Public ContactFabio Carmona
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Outcome results
None listed