Use of Chamomilla Recutita in Phlebitis

NCT ID: NCT00989599

Last Updated: 2009-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-09-30

Brief Summary

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To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis treatment, before dose response curve study and pilot study.

Detailed Description

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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

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Phlebitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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compress of Chamomilla recutita infusion

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

Group Type EXPERIMENTAL

compress of Chamomilla recutita infusion

Intervention Type OTHER

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 water

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

Group Type ACTIVE_COMPARATOR

compress of lukewarm water

Intervention Type OTHER

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

Interventions

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compress of Chamomilla recutita infusion

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

Intervention Type OTHER

compress of lukewarm water

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects with cancer who had infusion phlebitis during the administration of intravenous chemotherapy peripheral under hospitalization.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Escola de Enfermagem de Ribeirão Preto - USP

Principal Investigators

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Paula ED Reis, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Emília C Carvalho, RN, MsC, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Hospital de Base do Distrito Federal

Brasília, Brasília/DF, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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USPRecutita-01

Identifier Type: -

Identifier Source: org_study_id

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