The Effect of DBcare, a Food Supplement on Diabetes Control
Status
Conditions
Treatments
Details and patient eligibility
About
DBcare is a herbal food supplement that has been used over the years in India as a "traditional"anti-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.
Full 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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the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
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
35 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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