Diabetes mellitus type 2
Conditions
Interventions
Group I Moringa (Experimental): Moringa oleifera 6 capsules of Moringa powder 100% (400 mg) daily by oral route + Metformin hydrochloride 4 tablets USP 500mg daily by oral route during 4 months.
Group
Metformin
Tablets
Sponsors
Research Center for Protein Plants and Bionatural Products
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Adults 19-75 years 3. Initial HbA1c =7% = 9% 4. Patients who have given their informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who, before starting the study, present elevations of: glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, total bilirubin, or alkaline phosphatase greater than or equal to 2.5 times the institutional upper normal limit. 2. Patients who, before starting the study, present a glomerular filtration rate of less than 60 ml / min according to the Cockcroft-Gault formula. 3. Patients treated with steroids by any route of administration 3 months before starting the study. 4. Patients with unstable ischemic heart disease or decompensated arterial hypertension. 5. Patients being treated with insulin or another hypoglycemic agent other than Metformin. 6. Patients with decompensated diabetic complications that require treatment. 7. Anticoagulated patients or those with blood dyscrasias and hemolytic anemia. 8. Pregnant and postpartum and breastfeeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation of glycosylated hemoglobin values (difference of the baseline Hb1Ac value with respect to the final value). Measurement time: At baseline and, at 4 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and biochemical variables 1. Glycemic profile-PG (Laboratory values). Measurement time: At baseline and, 4 months. 2. Modifications in the treatment of the daily dose of Metformin hydrochloride USP 500mg (Difference: Starting dose - Dose after change (number of tablets), time of change). Measurement time: Up to 4 months. Safety: 1. Episodes of hypoglycemia. Measurement time: Up to 4 months 2. Episodes of hypotension. Measurement time: Up to 4 months 3. Adverse events (Occurrence of any AE (Yes, No), Type of AE (Name of the AE, Severity (Serious, Non-serious), Intensity (Mild, Moderate, Severe), Duration (It will be recorded by the start and end dates of the AE), Causation relationship (Very probable/Certain, Probable, Possible, Unlikely, Unrelated, Not evaluable/not classifiable), Attitude towards treatment (No changes, Temporary interruption, Definitive interruption of the treatment under study), Result of the AE (Recovered, Improved, Persists, Sequelae, Death due to AE, Unknown), Batch with which the EA is presented (The batch identification of the drug causing the AE will be collected). Measurement time: Up to 4 months. | — |
Countries
Cuba
Contacts
Public ContactConcepcion Campa Huerga
Research Center for Protein Plants and Bionatural Products
Outcome results
None listed