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Completed

NCT Number: NCT01341054

Use of Chamomilla Recutita in Mucositis

To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210080, Brazil

About this study

Population: adult subjects, submitted to hematopoietic stem cell transplantation (HSCT) at a cancer hospital in the interior of São Paulo State. The following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic HSCT and with intact oral cavity on the first day of conditioning. Subjects will be excluded if they present any adverse reaction to the active principles of Chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects over 18 years of age;
  • candidates for allogeneic HSCT;
  • with intact oral cavity on the first day of conditioning.

Exclusion criteria

  • present any adverse reaction to the active principles of Chamomilla recutita;
  • receive oral or intravenous anticoagulation therapy;
  • use oral or systemic topical anti-inflammatory medication;
  • receive any other type of intervention for mucositis not included in the standard oral care protocol.

Treatment and study plan

mouthwash with Chamomilla

Other

The Chamomile recutita mouthwash was administered two times daily for 30 days. 10 mL of this solution was swished around in the mouth for approximately one minute and then expectorated.

Standard oral care protocol

Other

The standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12% twice a day; oral hygiene teaching, recommended at least three times per day and always after meals. For brushing, brushes with extra-soft bristles and non-abrasive toothpaste are used. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it.

Primary outcomes

  1. Oral mucositis intensity

    Time frame: The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Chamomilla Recutita Use of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 25, 2011
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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