Use of Chamomilla Recutita in Mucositis
Ključne besede
Povzetek
Opis
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.
Datumi
| Nazadnje preverjeno: | 12/31/2012 |
| Prvič predloženo: | 04/18/2011 |
| Predviden vpis oddan: | 04/20/2011 |
| Prvič objavljeno: | 04/24/2011 |
| Zadnja posodobitev oddana: | 01/10/2013 |
| Zadnja posodobitev objavljena: | 01/13/2013 |
| Dejanski datum začetka študija: | 12/31/2010 |
| Predvideni datum primarnega zaključka: | 07/31/2011 |
| Predvideni datum zaključka študije: | 07/31/2011 |
Stanje ali bolezen
Intervencija / zdravljenje
Other: mouthwash with Chamomilla
Other: standard oral care protocol
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: mouthwash with Chamomilla extract 1% The Chamomile recutita mouthwash 1% was administered two times daily for 30 days. | |
| Experimental: mouthwash with Chamomilla extract 2% The Chamomile recutita mouthwash 2% was administered two times daily for 30 days. | |
| Active Comparator: standard oral care protocol The standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12%; oral hygiene teaching. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it. | 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. |
| Experimental: mouthwash with Chamomilla extract 0.5% The Chamomile recutita mouthwash 0.5% was administered two times daily for 30 days, starting on the first day of chemotherapy. |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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. |
Izid
Primarni izidni ukrepi
1. Oral mucositis intensity [The measurement will be held on the first day of the conditioning regimen to bone marrow grafting. In an expected average of 4 weeks]
