The Effect of DBcare, a Food Supplement on Diabetes Control - Full Text View

Sponsored by:	Meir Medical Center
Information provided by:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT00563004

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Non-Insulin Dependant Diabetes Mellitus Type 2 Diabetes Mellitus, on Oral Hypoglycemic Treatment Adult Type Diabetes Mellitus	Dietary Supplement: DBCARE

MedlinePlus related topics: Diabetes Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

Reduction of more than 0.5% GBA1C in the treatment group compared to placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Patients receive the herbal medication DBCARE for 3 months	Dietary Supplement: DBCARE Patients receive dbcare 2 tablets TID for 3 months
B: Placebo Comparator PATIENTS RECEIVE PLACEBO PILLS	Dietary Supplement: DBCARE PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563004

Locations

Israel
Meir Medical Center
KFAR-SABA, Israel, 44281

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator:

Pnina ROTMAN-PIKELNY, MD

Meir Medical Center

More Information

The influence of chromium chloride containing milk to glycemic control of patients with type 2 diabetes mellitus by Pei D et al. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	meir medical center ( Pnina Rotman Pikielny MD )
Study ID Numbers:	DBcare1, DBCARE01
Study First Received:	November 22, 2007
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00563004
Health Authority:	Israel: Ministry of Health

Keywords provided by Meir Medical Center:

Diabetes mellitus
Herbal treatment
Food supplement

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009