NCT00563004

The Effect of DBcare, a Food Supplement on Diabetes Control

A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the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

Conditions

• Diabetes Mellitus, Non-insulin Dependant
• Diabetes Mellitus Type 2
• Diabetes Mellitus, on Oral Hypoglycemic Treatment
• Adult Type Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DBCARE	Patients receive dbcare 2 tablets TID for 3 months
DIETARY_SUPPLEMENT	DBCARE	PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-12-01
• Completion: 2011-09-01
• First posted: 2007-11-26
• Last updated: 2013-02-28

Locations

1 site across 1 country: Israel