DiabetesNCT02760017
Bauhinia Forficata in Diabetic Patients
A study testing B. forficata in people with Diabetes, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
Trial summary
Among the plants most used in folk medicine for the treatment of diabetes are the species of the genus Bauhinia (Fabaceae), popularly known in Brazil as "pata-de-vaca". Of these, Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- B. forficata
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Sep 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetic patients
- Using oral antidiabetic treatment for at least 3 months
- Glycated hemoglobin levels > 7.5% or
- Fasting glucose levels >=100mg/dl
Who cannot join
- Type 1 diabetes patients
- History of cancer under treatment
- Major cardiovascular event during the last 90 days (eg. stroke, myocardial infarction)
- Pregnancy
- Lactation
- Serious diseases presenting limited short-term prognosis (eg stage IV COPD end-stage heart failure)
- Child B or C cirrhotic patients
- Patients with chronic renal failure on dialysis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Extremo Sul Catarinense
Criciúma, Santa Catarina, 88801450
About this study
Official title: Evaluation of Clinical Efficacy Capsules Containing Standardized Extract of Bauhinia Forficata (Pata- De-vaca) in Diabetic Patients
Among the plants most used in folk medicine for the treatment of diabetes are the species of the genus Bauhinia (Fabaceae), popularly known in Brazil as "pata-de-vaca". Of these, Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due to this fact it is included in the Medicinal Plants List of the Brazilian Public Health System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its chemical composition and its pharmacological potential. From the chemical point of view the main components identified in hydro alcoholic extract of the leaves are O-glycosylated derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity of B. forficata in clinical level was performed in only two studies, both with few patients, and questionable methodological quality that used tea as a pharmaceutical form, a fact that allows us to question the validity of data considering the risks of no dose reproducibility ingested by patients during the study. Thus the investigators here intend to determine the effects of a standardized extract of B. forficata in the control of patients with diabetes mellitus
- Conditions
- Diabetes
- Being tested
- B. forficata, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. forficataDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | capsules containing placebo for B forticata Receives: Drug: Placebo |
| B. forficata | Experimental | capsules of B. forficata containing 200 mg of plant extracts Receives: Drug: B. forficata |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin levels
Measured: 4 months
fasting glucose levels
Measured: 4 months
Secondary outcomes (3)
Plasma inflammatory parameters levels
Interleukin-6 and c-reactive protein levels
Measured: 4 months
Plasma oxidative stress parameters levels
Advanded glycation end-products, protein carbonyl and lipid peroxidation levels
Measured: 4 months
Plasma endothelin-1 levels
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionSep 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760017
- Sponsor's protocol ID
- 401336/2013-1
- Status last verified
- Jun 2018
- First submitted
- 28 Apr 2016
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy Capsules Containing Standardized Extract of Bauhinia Forficata (Pata- De-vaca) in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02760017
- Acronym / sponsor ID
- 401336/2013-1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 May 2016 (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.
Among the plants most used in folk medicine for the treatment of diabetes are the species of the genus Bauhinia (Fabaceae), popularly known in Brazil as "pata-de-vaca". Of these, Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due to this fact it is included in the Medicinal Plants List of the Brazilian Public Health System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its chemical composition and its pharmacological potential. From the chemical point of view the main components identified in hydro alcoholic extract of the leaves are O-glycosylated derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity of B. forficata in clinical level was performed in only two studies, both with few patients, and questionable methodological quality that used tea as a pharmaceutical form, a fact that allows us to question the validity of data considering the risks of no dose reproducibility ingested by patients during the study. Thus the investigators here intend to determine the effects of a standardized extract of B. forficata in the control of patients with diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebocapsules containing placebo for B forticata |
| B. forficata | Experimental | Drug: B. forficatacapsules of B. forficata containing 200 mg of plant extracts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type II diabetic patients
- Using oral antidiabetic treatment for at least 3 months
- Glycated hemoglobin levels > 7.5% or
- Fasting glucose levels >=100mg/dl
Key exclusion criteria (8 listed)
- Type 1 diabetes patients
- History of cancer under treatment
- Major cardiovascular event during the last 90 days (eg. stroke, myocardial infarction)
- Pregnancy
- Lactation
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 |
|---|---|---|
| B. forficata | Drug | B. forficata |
| Placebo | Drug | placebo |
Primary outcome
glycated hemoglobin levels
Time frame: 4 months
fasting glucose levels
Time frame: 4 months
3 secondary outcomes
Plasma inflammatory parameters levels
Time frame: 4 months
Plasma oxidative stress parameters levels
Time frame: 4 months
Plasma endothelin-1 levels
Time frame: 4 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 12 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. forficata in people with Diabetes, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude 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 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 12 Jun 2018. 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. 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?
glycated hemoglobin levels (time frame: 4 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 12 Jun 2018.