The Effect of DBcare, a Food Supplement on Diabetes Control

Study Overview
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Brief Summary
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DBcare is a herbal food supplement that has been used over the years in India as a traditionalanti-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
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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month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of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12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the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

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

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

Intervention / Treatment
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* Dietary Supplement: DBCARE
* Dietary Supplement: DBCARE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Herbal treatment, Food supplement