Use of Chamomilla Recutita in Phlebitis

Phase 3

Completed

• Conditions: Phlebitis
• Interventions: Other: compress of Chamomilla recutita infusion; Other: compress of lukewarm water

• Registration Number: NCT00989599
• Lead Sponsor: University of Sao Paulo

Brief Summary

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 Timeline

• Study Start: 2004-09
• Primary Completion: 2007-12
• Study Completion: 2008-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Last Update Submitted: 2009-10-02
• Study First Posted: 2009-10-05
• Last Update Posted: 2009-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compress of Chamomilla recutita infusion	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
compress of lukewarm water	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

Primary Outcome Measures

Name	Time	Method
phlebitis regression time	medium of 7 days

Secondary Outcome Measures

Name	Time	Method
palpable venous cord regression time	72 hours

Trial Locations

Locations (1)

Hospital de Base do Distrito Federal; 🇧🇷 Brasília, Brasília/DF, Brazil