Use of Chamomilla Recutita in Phlebitis

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00989599
First received: October 2, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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:


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 April 17, 2014