Diabetes Mellitus, Non-insulin DependantNCT00563004
The Effect of DBcare, a Food Supplement on Diabetes Control
A study testing DBCARE in people with Diabetes Mellitus, Non-insulin Dependant and Diabetes Mellitus Type 2, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Non-insulin Dependant, Diabetes Mellitus Type 2, Diabetes Mellitus, on Oral Hypoglycemic Treatment
- What is being tested?
- DBCARE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- DBCARE
- Keywords
- Diabetes mellitus, Herbal treatment, Food supplement
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBCAREDietary supplement
Patients receive dbcare 2 tablets TID for 3 months
DBCAREDietary supplement
PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients receive the herbal medication DBCARE for 3 months Receives: Dietary Supplement: DBCARE |
| B | Placebo comparator | PATIENTS RECEIVE PLACEBO PILLS Receives: Dietary Supplement: DBCARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
Measured: 3 months
Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo
Measured: 3 months
Secondary outcomes (1)
Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-insulin DependantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pninarotman, Meir Medical Center
- Investigators
- Pnina ROTMAN-PIKELNY, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563004
- Sponsor's protocol ID
- DBcare1
- Other IDs
- DBCARE01
- Status last verified
- Feb 2013
- First submitted
- 22 Nov 2007
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control
- ClinicalTrials.gov ID
- NCT00563004
- Acronym / sponsor ID
- DBcare1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: DBCAREPatients receive the herbal medication DBCARE for 3 months |
| B | Placebo comparator | Dietary Supplement: DBCAREPATIENTS RECEIVE PLACEBO PILLS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBCAREPatients receive dbcare 2 tablets TID for 3 months | Dietary supplement | A |
| DBCAREPLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS | Dietary supplement | B |
Primary outcome
Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
Time frame: 3 months
Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo
Time frame: 3 months
1 secondary outcome
Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
Related trials for Diabetes Mellitus, Non-insulin Dependant
Active, not recruiting
Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
Type 2 Diabetes Mellitus (T2DM), Continuous Glucose Measurement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pnina ROTMAN-PIKELNY, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBCARE in people with Diabetes Mellitus, Non-insulin Dependant and Diabetes Mellitus Type 2, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of more than 0.5% GBA1C in the treatment group compared to placebo (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.