Clinical trial NCT00563004: The Effect of DBcare, a Food Supplement on Diabetes Control
Official title: A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-insulin Dependant
Diabetes Mellitus Type 2
Diabetes Mellitus, on Oral Hypoglycemic Treatment
Adult Type Diabetes Mellitus
Keywords: Diabetes mellitus
Herbal treatment
Food supplement
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2007-11-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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

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

Primary outcomes:
measure: Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
timeFrame: 3 months
measure: Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo
timeFrame: 3 months
Secondary outcomes:
measure: Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Kfar-saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Pnina ROTMAN-PIKELNY, MD
role: PRINCIPAL_INVESTIGATOR
References: