PhlebitisPhase 3NCT00989599
Use of Chamomilla Recutita in Phlebitis
A Phase 3 study testing compress of Chamomilla recutita infusion and compress of lukewarm water in people with Phlebitis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis treatment, before dose response curve study and pilot study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phlebitis
- What is being tested?
- compress of Chamomilla recutita infusion and compress of lukewarm water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2004to Sep 2008
- Phase
- Phase 3
- 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
- Subjects with cancer who had infusion phlebitis during the administration of intravenous chemotherapy peripheral under hospitalization.
Who cannot join
- Report made by the subject of study, prior hypersensitivity reaction or presentation during the research, adverse reaction to chamomile or any plant of the family Asteraceae ou Compositae: margarida (Aster tripolium), crisântemo (Chrysanthemum leucanthemum), artemísia or isopo santo (Artemísia vulgaris), carpineira or ambrósia americana (Ambrosia artemisiifolia) and senécio (Senecio jacobaea L.);
- Prescription during the process of data collection, some kind of anti-inflammatory with systemic or topical activity where it was located phlebitis, and, upon the occurrence of bacterial phlebitis, had been prescribed topical or systemic antibiotic therapy;
- Refusal of the subject to participate in the study, regardless of the time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Topic Use of Chamomilla Recutita in Phlebitis Due to Peripheral Intravenous Therapy
To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis treatment, before dose response curve study and pilot study.
Read the detailed description
The hypothesis adopted was that patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day, would present a shorter phlebitis regression time in comparison with patients treated with a lukewarm water compress.
- Conditions
- Phlebitis
- Being tested
- compress of Chamomilla recutita infusion, compress of lukewarm water
- Keywords
- phlebitis, Chamomilla recutita, Catheterization peripheral
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compress of Chamomilla recutita infusionOther
Patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy were treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day
compress of lukewarm waterOther
Patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, in control group, were treated with a compress of lukewarm water for 20 minutes three times per day
| Study group | Role | What they receive |
|---|---|---|
| compress of Chamomilla recutita infusion | Experimental | Patients who developed phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy were treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day Receives: Other: compress of Chamomilla recutita infusion |
| compress of lukewarm water | Active comparator | Patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, in control group, were treated with a compress of lukewarm water for 20 minutes three times per day Receives: Other: compress of lukewarm water |
What is being measured
The primary outcome is the main question the study is designed to answer.
phlebitis regression time
Measured: medium of 7 days
Secondary outcomes (1)
palpable venous cord regression time
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhlebitisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Paula ED Reis, RN, PhD, Principal investigator, University of Sao PauloEmília C Carvalho, RN, MsC, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989599
- Sponsor's protocol ID
- USPRecutita-01
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Topic Use of Chamomilla Recutita in Phlebitis Due to Peripheral Intravenous Therapy
- ClinicalTrials.gov ID
- NCT00989599
- Acronym / sponsor ID
- USPRecutita-01
- Conditions
- Phlebitis
- Keywords
- phlebitis, Chamomilla recutita, Catheterization peripheral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Oct 2009 (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.
To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis treatment, before dose response curve study and pilot study.
Detailed description
The hypothesis adopted was that patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day, would present a shorter phlebitis regression time in comparison with patients treated with a lukewarm water compress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compress of Chamomilla recutita infusion | Experimental | Other: compress of Chamomilla recutita infusionPatients who developed phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy were treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day |
| compress of lukewarm water | Active comparator | Other: compress of lukewarm waterPatients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, in control group, were treated with a compress of lukewarm water for 20 minutes three times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with cancer who had infusion phlebitis during the administration of intravenous chemotherapy peripheral under hospitalization.
Key exclusion criteria (3 listed)
- Report made by the subject of study, prior hypersensitivity reaction or presentation during the research, adverse reaction to chamomile or any plant of the family Asteraceae ou Compositae: margarida (Aster tripolium), crisântemo (Chrysanthemum leucanthemum), artemísia or isopo santo (Artemísia vulgaris), carpineira or ambrósia americana (Ambrosia artemisiifolia) and senécio (Senecio jacobaea L.);
- Prescription during the process of data collection, some kind of anti-inflammatory with systemic or topical activity where it was located phlebitis, and, upon the occurrence of bacterial phlebitis, had been prescribed topical or systemic antibiotic therapy;
- Refusal of the subject to participate in the study, regardless of the time.
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 |
|---|---|---|
| compress of Chamomilla recutita infusionPatients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy were treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day | Other | compress of Chamomilla recutita infusion |
| compress of lukewarm waterPatients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, in control group, were treated with a compress of lukewarm water for 20 minutes three times per day | Other | compress of lukewarm water |
Primary outcome
phlebitis regression time
Time frame: medium of 7 days
1 secondary outcome
palpable venous cord regression time
Time frame: 72 hours
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 5 Oct 2009.
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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.
Paula ED Reis, RN, PhD principal investigator
University of Sao Paulo
Emília C Carvalho, RN, MsC, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing compress of Chamomilla recutita infusion and compress of lukewarm water in people with Phlebitis, run by University of Sao Paulo 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 1 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 5 Oct 2009. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
phlebitis regression time (time frame: medium of 7 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 5 Oct 2009.