Clinical Trial Details
| Trial ID: | L2963 |
| Source ID: | NCT00795704 |
| Associated Drug: | Mulberry Leaf Extract |
| Title: | Impact of Mulberry Leaf on Type 2 Diabetes |
| Acronym: | Mul-DM |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00795704/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Mulberry Leaf Extract|DRUG: Placebo |
| Outcome Measures: | Primary: Hemoglobin A1C, 3 month minus baseline | Secondary: Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels, Sodium (\>150 mmol/L), Potassium (\>5 mmol/L), Bicarbonate (\>34 mmol/L), Chloride (\>110 mmol/L), Serum Creatinine (\>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (\>11 mg/L), Alanine Aminotransferase (\>3 times baseline), Aspartate Aminotransferase (\>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported., Baseline, 1 month, and 3 months|Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages, 2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline., Baseline and 3 months |
| Sponsor/Collaborators: | Sponsor: University of Mississippi Medical Center |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2|PHASE3 |
| Enrollment: | 24 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-04 |
| Completion Date: | 2010-05 |
| Results First Posted: | 2012-08-09 |
| Last Update Posted: | 2012-08-09 |
| Locations: | University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States |
| URL: | https://clinicaltrials.gov/show/NCT00795704 |

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