The Effect of DBcare, a Food Supplement on Diabetes Control

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563004
• Other study ID #: DBcare1
• Secondary ID: DBCARE01
• Status: Completed
• Phase: N/A
• First received: November 22, 2007
• Last updated: February 27, 2013
• Start date: August 2008
• Est. completion date: September 2011

Study information

• Verified date: February 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• DBCARE
Patients receive dbcare 2 tablets TID for 3 months
• DBCARE
PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of more than 0.5% GBA1C in the treatment group compared to placebo		3 months	No
Primary	Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo		3 months	No
Secondary	Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline		3 months	No

External Links

•   The influence of chromium chloride containing milk to glycemic control of patients with type 2 diabetes mellitus by Pei D et al.