Use of Chamomilla Recutita in Phlebitis

NCT00989599 | Completed Phase 3 DMC

• 1 other identifier: USPRecutita-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Phlebitis

Keywords

phlebitis; Chamomilla recutita; Catheterization peripheral

Outcome Measures

Primary Outcomes (1)

• phlebitis regression time

  medium of 7 days

Secondary Outcomes (1)

• palpable venous cord regression time

  72 hours

Study Arms (2)

compress of Chamomilla recutita infusion

EXPERIMENTAL

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

compress of lukewarm water

ACTIVE COMPARATOR

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

Interventions

compress of Chamomilla recutita infusion OTHER

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 Chamomilla recutita infusion

compress of lukewarm water OTHER

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

compress of lukewarm water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with cancer who had infusion phlebitis during the administration of intravenous chemotherapy peripheral under hospitalization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Brasília/DF, Brazil

Location

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Paula ED Reis, RN, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Emília C Carvalho, RN, MsC, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 5, 2009
• Study Start: September 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: October 5, 2009

Record last verified: 2009-10

Locations

BR (1)