DiabetesPhase 1/2NCT01145534
Evaluation of Cissus Verticillata L. Infusion in Controlling Type 2 Diabetes
A Phase 1/2 study testing glibenclamide and medicinal plant infusion in people with Diabetes, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- glibenclamide and medicinal plant infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Oct 2009
- Phase
- Phase 1/2
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects of 30 up to 80 years of age
- positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dL)
- patients that signed the informed consent
Who cannot join
- patients with renal and hepatic disfunction,
- patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems)
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration
The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients.
Read the detailed description
Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. In many developing countries, this condition is regarded as major public health problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. As Diabetes progresses, medications are necessary to control glucose levels.
The aim of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been used as potential medication for controlling glucose levels in Diabetes patients. Few studies have explored this effect related to Cissus verticillata L.infusion, though it has been indicated by folk medicine of some Latin American countries.
- Conditions
- Diabetes
- Being tested
- glibenclamide, medicinal plant infusion
- Keywords
- diabetes,, medicinal plants,, glucose
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glibenclamideDrug
Also called Glibenclamida, Legrand GE
5 mg as pills, taken daily during the morning for 60 days
medicinal plant infusionOther
Also called popular plant name: Insulina
INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Glibenclamide | Active comparator | Patients used 5 mg glibenclamide daily for 60 days Receives: Drug: glibenclamide |
| Experimental | Experimental | Patients ingested the infusion of Cissus verticillata L. prepared as 1 g in 150 mL of hot water for 10 min. This was done daily for 60 days Receives: Other: medicinal plant infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.
Measured: 60 days
Secondary outcomes (1)
Salivary glucose level
The level of glucose in saliva was measured in laboratory after colleting non-stimulated saliva in test tubes.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Fabio C Sampaio, PhD, Study chair, Federal University fo Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145534
- Sponsor's protocol ID
- UFPB-0346
- Status last verified
- Aug 2008
- First submitted
- 15 Jun 2010
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration
- ClinicalTrials.gov ID
- NCT01145534
- Acronym / sponsor ID
- UFPB-0346
- Conditions
- Diabetes
- Keywords
- diabetes,, medicinal plants,, glucose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Jun 2010 (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.
The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients.
Detailed description
Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. In many developing countries, this condition is regarded as major public health problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. As Diabetes progresses, medications are necessary to control glucose levels.
The aim of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been used as potential medication for controlling glucose levels in Diabetes patients. Few studies have explored this effect related to Cissus verticillata L.infusion, though it has been indicated by folk medicine of some Latin American countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glibenclamide | Active comparator | Drug: glibenclamidePatients used 5 mg glibenclamide daily for 60 days |
| Experimental | Experimental | Other: medicinal plant infusionPatients ingested the infusion of Cissus verticillata L. prepared as 1 g in 150 mL of hot water for 10 min. This was done daily for 60 days |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects of 30 up to 80 years of age
- positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dL)
- patients that signed the informed consent
Key exclusion criteria (3 listed)
- patients with renal and hepatic disfunction,
- patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems)
- pregnant women
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 |
|---|---|---|
| glibenclamideAlso: Glibenclamida, Legrand GE5 mg as pills, taken daily during the morning for 60 days | Drug | Glibenclamide |
| medicinal plant infusionAlso: popular plant name: InsulinaINfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days. | Other | Experimental |
Primary outcome
blood glucose
Time frame: 60 days
Blood glucose was measured using a Gluco Dr. Plus (AGM-3000) Blood Glucose Monitoring System.
1 secondary outcome
Salivary glucose level
Time frame: 60 days
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 9 Nov 2011.
- Official research group for studies related to medicinal plantsLink provided by the sponsor.
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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.
Fabio C Sampaio, PhD study chair
Federal University fo Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing glibenclamide and medicinal plant infusion in people with Diabetes, run by Federal University of Paraíba at 1 site in Brazil.
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 3 inclusion and 3 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 9 Nov 2011. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
blood glucose (time frame: 60 days). 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 9 Nov 2011.