Use of Chamomilla Recutita in Phlebitis

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Phlebitis

Treatments: Other: compress of Chamomilla recutita infusion; Other: compress of lukewarm water

Study type: Interventional

Funder types: Other

Identifiers

NCT00989599

USPRecutita-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

compress of Chamomilla recutita infusion

Experimental group

Description:

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

Treatment:

Other: compress of Chamomilla recutita infusion

compress of lukewarm water

Active Comparator group

Description:

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

Treatment:

Other: compress of lukewarm water