The Effect of DBcare, a Food Supplement on Diabetes Control

February 27, 2013 updated by: pninarotman, Meir Medical Center

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

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.

Study Overview

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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the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

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kfar-saba, Israel, 44281
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Patients receive the herbal medication DBCARE for 3 months
Patients receive dbcare 2 tablets TID for 3 months
PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS
Placebo Comparator: B
PATIENTS RECEIVE PLACEBO PILLS
Patients receive dbcare 2 tablets TID for 3 months
PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
Time Frame: 3 months
3 months
Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pnina ROTMAN-PIKELNY, MD, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 22, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type 2

3
Subscribe