The Effect of DBcare, a Food Supplement on Diabetes Control

NCT ID: NCT00563004

Last Updated: 2013-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-09-30

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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Patients receive the herbal medication DBCARE for 3 months

Group Type: ACTIVE_COMPARATOR

DBCARE

Intervention Type: DIETARY_SUPPLEMENT

Patients receive dbcare 2 tablets TID for 3 months

B

PATIENTS RECEIVE PLACEBO PILLS

Group Type: PLACEBO_COMPARATOR

DBCARE

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS

Interventions

DBCARE

Patients receive dbcare 2 tablets TID for 3 months

Intervention Type: DIETARY_SUPPLEMENT

DBCARE

PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

pninarotman

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pnina ROTMAN-PIKELNY, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

DBCARE01

Identifier Type: -

Identifier Source: secondary_id

DBcare1

Identifier Type: -

Identifier Source: org_study_id