Use of Chamomilla Recutita in Phlebitis - Full Text View

Purpose

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

Condition	Intervention	Phase
Phlebitis	Other: compress of Chamomilla recutita infusion Other: compress of lukewarm water	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Therapeutic Topic Use of Chamomilla Recutita in Phlebitis Due to Peripheral Intravenous Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Drinking Water

Drug Information available for: Chamomile Camomile, german

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

phlebitis regression time [ Time Frame: medium of 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

palpable venous cord regression time [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Enrollment:	123
Study Start Date:	September 2004
Study Completion Date:	September 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Other: 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
Active Comparator: 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	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989599

Locations

Brazil
Hospital de Base do Distrito Federal
Brasília, Brasília/DF, Brazil

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:	Paula ED Reis, RN, PhD	University of Sao Paulo
Study Director:	Emília C Carvalho, RN, MsC, PhD	University of Sao Paulo

More Information

No publications provided

Responsible Party:	Paula Elaine Diniz dos Reis, Escola de Enfermagem de Ribeirão Preto - USP
ClinicalTrials.gov Identifier:	NCT00989599 History of Changes
Other Study ID Numbers:	USPRecutita-01
Study First Received:	October 2, 2009
Last Updated:	October 2, 2009
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

phlebitis
Chamomilla recutita
Catheterization peripheral

Additional relevant MeSH terms:

Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on June 17, 2013