Use of Chamomilla Recutita in Phlebitis

Phlebitis Clinical Trial

Official title:

Therapeutic Topic Use of Chamomilla Recutita in Phlebitis Due to Peripheral Intravenous Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989599
• Other study ID #: USPRecutita-01
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2009
• Last updated: October 2, 2009
• Start date: September 2004
• Est. completion date: September 2008

Study information

• Verified date: October 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phlebitis

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Base do Distrito Federal	Brasília	Brasília/DF

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phlebitis regression time		medium of 7 days	Yes
Secondary	palpable venous cord regression time		72 hours	Yes