Back to resultsUse of Chamomilla Recutita in Phlebitis
Primary Purpose
Phlebitis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
compress of Chamomilla recutita infusion
compress of lukewarm water
Sponsored by
About this trial
This is an interventional treatment trial for Phlebitis focused on measuring phlebitis, Chamomilla recutita, Catheterization peripheral
Eligibility Criteria
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.
Sites / Locations
- Hospital de Base do Distrito Federal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
compress of Chamomilla recutita infusion
compress of lukewarm water
Arm 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
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
Outcomes
Primary Outcome Measures
phlebitis regression time
Secondary Outcome Measures
palpable venous cord regression time
Full Information
NCT ID
NCT00989599
First Posted
October 2, 2009
Last Updated
October 2, 2009
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00989599
Brief Title
Use of Chamomilla Recutita in Phlebitis
Official Title
Therapeutic Topic Use of Chamomilla Recutita in Phlebitis Due to Peripheral Intravenous Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phlebitis
Keywords
phlebitis, Chamomilla recutita, Catheterization peripheral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
compress of Chamomilla recutita infusion
Arm Type
Experimental
Arm 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
Arm Title
compress of lukewarm water
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
compress of Chamomilla recutita infusion
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
compress of lukewarm water
Intervention 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
Primary Outcome Measure Information:
Title
phlebitis regression time
Time Frame
medium of 7 days
Secondary Outcome Measure Information:
Title
palpable venous cord regression time
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula ED Reis, RN, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emília C Carvalho, RN, MsC, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Base do Distrito Federal
City
Brasília
State/Province
Brasília/DF
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Use of Chamomilla Recutita in Phlebitis
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