The Effect of DBcare, a Food Supplement on Diabetes Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
pninarotman, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00563004
First received: November 22, 2007
Last updated: February 27, 2013
Last verified: February 2013
  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

Study Type: Interventional
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
Official Title: A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control

Resource links provided by NLM:


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 ]

Enrollment: 35
Study Start Date: August 2008
Study Completion Date: September 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients receive the herbal medication DBCARE for 3 months
Dietary Supplement: DBCARE
Patients receive dbcare 2 tablets TID for 3 months
Placebo Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: pninarotman, DR, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00563004     History of Changes
Other Study ID Numbers: DBcare1, DBCARE01
Study First Received: November 22, 2007
Last Updated: February 27, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Diabetes mellitus
Herbal treatment
Food supplement

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014