Adult Type Diabetes Mellitus, Diabetes Mellitus, Non-insulin Dependant, Diabetes Mellitus, on Oral Hypoglycemic Treatment, Diabetes Mellitus Type 2
Conditions
Keywords
Diabetes mellitus, Herbal treatment, Food supplement
Brief summary
DBcare is a herbal food supplement that has been used over the years in India as a traditionalanti-diabetic formula.DBcare was not tested controlled trials in humans, yet.We intend to test the ability of DBCare to improve blood sugar level control in patients with uncontrolled diabetes.
Detailed description
Study design: prospective, randomized, single-blind, placebo-controlled trial Inclusion criteria: Men and women (older than 18 years old) with type 2 diabetes and inadequate glycemic control, defined by HbA1C 8% ³ £10%. Previous medications include any oral hypoglycemic agents, as monotherapy or in combination. Concurrent lipid-lowering, anti-hypertensive and other medications are allowed Exclusion criteria (before the study): Type 1 diabetes mellitus Pregnant or lactating women Insulin treatment 3 months prior to study entry Creatinine \>2 mg/dL Abnormal liver function tests GOT\>X2 or GPT\>X2 the upper normal limit Unstable anginal syndrome Congestive heart failure (NYHA class I-IV) Inability to follow study instructions including low compliance Exclusion criteria (during the study): Severe hypoglycemia (less than 50 mg%) or any hypoglycemic event requiring intravenous glucose infusion Number of patients: 30 patients (drug) 30 patients (placebo) Design: Four out-patient visits, at enrollment and every month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the morning, on a daily basis Drugs: identical drug containing/ placebo capsules Drugs for a month will be given in each monthly visit Dose: 2 tablets three times daily
Interventions
DIETARY_SUPPLEMENTDBCARE
Patients receive dbcare 2 tablets TID for 3 months
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \>18y * With type 2 diabetes mellitus and inadequate glycemic control * HBA1C \>8 \<10 * Previous medications include oral hypoglycemic medications,as monotherapy or in combination
Exclusion criteria
* Type 1 diabetes mellitus * Pregnant or lactating women * Insulin treatment 3 months prior to study entry * Creatinine \>2 * Abnormal liver function test GOT\>2 or GPT\>2 the upper limit of norm * Unstable anginal syndrome * Congestive heart failure NYHA 1-4 * Inability to follow study instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo | 3 months |
| Reduction of more than 0.5% GBA1C in the treatment group compared to placebo | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline | 3 months |
Countries
Israel
Outcome results
None listed