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

October 2, 2009
October 2, 2009
September 2004
December 2007   (final data collection date for primary outcome measure)
phlebitis regression time [ Time Frame: medium of 7 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
palpable venous cord regression time [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Use of Chamomilla Recutita in Phlebitis
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Phlebitis
  • 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
  • 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
  • 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
    Intervention: Other: compress of Chamomilla recutita infusion
  • 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
    Intervention: Other: compress of lukewarm water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
September 2008
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00989599
USPRecutita-01
Yes
Paula Elaine Diniz dos Reis, Escola de Enfermagem de Ribeirão Preto - USP
University of Sao Paulo
Not Provided
Principal Investigator: Paula ED Reis, RN, PhD University of Sao Paulo
Study Director: Emília C Carvalho, RN, MsC, PhD University of Sao Paulo
University of Sao Paulo
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP