ClinicalTrials.gg
CompletedNCT00989599Updated Oct 5, 2009

Use of Chamomilla Recutita in Phlebitis

A Phase 3 interventional study of compress of Chamomilla recutita infusion and compress of lukewarm water in Phlebitis, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-05.

Sponsored by University of Sao Paulo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Phlebitis

Browse trials for

Keywords

  • phlebitis
  • Chamomilla recutita
  • Catheterization peripheral
03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's enrollment of 123 is close to the median of 134 across 38 interventional studies indexed under Phlebitis.

Browse Phlebitis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Report made by the subject of study, prior 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    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

    Other: compress of Chamomilla recutita infusion

  • Active comparator
    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

    Other: compress of lukewarm water

Interventions

  • Othercompress 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

  • Othercompress 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

06

What researchers measure

Primary outcomes

  1. phlebitis regression time

    Time frame: medium of 7 days

Secondary outcomes

  1. palpable venous cord regression time

    Time frame: 72 hours

07

Study locations

1 site
  • Hospital de Base do Distrito Federal
    Brasília, Brasília/DF, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00989599
First posted
Oct 5, 2009
Start date
Sep 2004
Primary completion
Dec 2007
Completion
Sep 2008
Last update
Oct 5, 2009

Study contacts

Paula ED Reis, RN, PhD
principal investigator · University of Sao Paulo
Emília C Carvalho, RN, MsC, PhD
study director · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion