NCT01341054

Use of Chamomilla Recutita in Mucositis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Mucositis

Interventions

Type	Name	Description
OTHER	mouthwash with Chamomilla	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.
OTHER	Standard oral care protocol	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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-04-25
• Last updated: 2023-05-15

Locations

1 site across 1 country: Brazil