| Revision date | Field name | Previous value |
|---|---|---|
| September 18, 2016 | summary | Background and the Purpose of the Study: stomatitis is a disturbing and prevalent side-effect of chemotherapy that disturbs patients and causes difficulties in patient’s drinking, eating and talking, and may results in infection and bleeding and eventually decrease quality of life .This study aimed to investigate the effect of the marshmallow root extract on treatment of Stomatitis due chemotherapy.<br /> Materials and Methods: This randomized controlled trial study was conducted during 2016.The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran. In this study, 50 patients diagnosed with cancerthat undergoing chemoterapy were randomly assigned into control and experimental groups in similar blocks according to their stomatitis severity. In this study; patient, the nurse examined mouth the patient and give mouthwash solution to the patient were not aware from the content of the solutions. Severity of stomatitis in experimental and control groups is similar.<br /> Inclusion criteria: undergoing chemotherapy; age above18 years old; having consciousness; consent for participation in the study; no history of underlying disease (allergy, allergic rhinitis, asthma ) and hypersensitivity and immune system illness;; no use another mouthwash solution during the study; do not receive systemic antibiotic or anti fungi agents; not doing radiotherapy during treatment; lack of sensitivity to plants.<br /> Exclusion criteria: receiving radiotherapy during treatment; use from another solution mouthwash during the study; the decision to withdraw from the study; irregular use of mouthwash solution (frequency, amount:No mouthwash more than once a day or more than 10 times a week Also,if the volume of the solution used in the mouthwash every time isbe less than 10cc); sensitivity to plants and received systemic antibiotics and anti fungi agents at the beginning or during the study. To all patients after admission, are given routine solution (that contain dexamethason، lidocaine2%, syrp: Al-mg-s , syrp: diphenhydramine and sucralfate) mixed with aqueous extract of the Marshmallow (Althaeaofficinalis) root (glass 1 (experimental)) and the routine solution (lidocaine2℅ , dexamethasone, sucralfate, diphenhydramine and Al-mg-s surup)(glass 2(control)). Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after mouth wash. Oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a nurse working in oncology ward who does not know the mouthwash solution and then stomatitis checklist is completed. |
| October 28, 2016 | Trial acronym | Marshmallow root and ostomatitis |
| October 28, 2016 | Intervention/Control 1 | The intervention group use solution of routine mouthwash plus aqueous extract of marshmallow root that each 100m.l of that contains :dexamethasone 4 mg ,lidocaine 2% 50 mg , Al-mg-s syrup 30 ml ,Diphen hydramine surp15cc(37.5mg), sucralfate750 mg and 50 cc extract marshmallow root 8% (glass 1) .Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.<br /> |
| October 2, 2017 | Condition studied 1 | ostomstitis |
| November 20, 2016 | Intervention/Control 2 | control group use routine mouthwash solution that100 ml of that containing :dexamethasone 8mg , lidocaine 2%100mg, Al-mg-s syrup60 ml , Diphenhydramine syrup 30 cc(75mg) , tab of sucralfate 1500mg (glass 2). Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after.oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed. |
| November 20, 2016 | Intervention/Control 1 | The intervention group use solution of routine mouthwash plus aqueous extract of marshmallow root that each 100m.l of that contains :dexamethasone 4 mg ,lidocaine 2% 50 mg , Al-mg-s syrup 30 ml ,Diphen hydramine surp15cc(37.5mg), sucralfate750 mg and 50 cc extract marshmallow root 8% (glass 1) .Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.<br /> |
| July 29, 2016 | Other design features | |
| July 29, 2016 | Scientific title | Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis |
| July 29, 2016 | summary | Background and the Purpose of the Study: stomatitis is a disturbing and prevalent side-effect of chemotherapy that disturbs patients and causes difficulties in patient’s drinking, eating and talking, and may results in infection and bleeding and eventually decrease quality of life .This study aimed to investigate the effect of the marshmallow root extract on treatment of Stomatitis due chemotherapy.<br /> Materials and Methods: This randomized controlled trial study was conducted during 2016.The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran. In this study, 50 patients diagnosed with cancerthat undergoing chemoterapy were randomly assigned into control and experimental groups in similar blocks according to their stomatitis severity. In this study; patient, the nurse examined mouth the patient and give mouthwash solution to the patient were not aware from the content of the solutions. Severity of stomatitis in experimental and control groups is similar.<br /> Inclusion criteria: undergoing chemotherapy; age above18 years old; having consciousness; consent for participation in the study; no history of underlying disease (allergy, allergic rhinitis, asthma ) and hypersensitivity and immune system illness;; no use another mouthwash solution during the study; do not receive systemic antibiotic or anti fungi agents; not doing radiotherapy during treatment; lack of sensitivity to plants.<br /> Exclusion criteria: receiving radiotherapy during treatment; use from another solution mouthwash during the study; the decision to withdraw from the study; irregular use of mouthwash solution (frequency, amount:No mouthwash more than once a day or more than 10 times a week Also,if the volume of the solution used in the mouthwash every time isbe less than 10cc); sensitivity to plants and received systemic antibiotics and anti fungi agents at the beginning or during the study. To all patients after admission, are given routine solution (that contain dexamethason، lidocaine2%, syrp: Al-mg-s , syrp: diphenhydramine and sucralfate) mixed with aqueous extract of the Marshmallow (Althaeaofficinalis) root (glass 1 (experimental)) and the routine solution (lidocaine2℅ , dexamethasone, sucralfate, diphenhydramine and Al-mg-s surup)(glass 2(control)). Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after mouth wash. Oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a nurse working in oncology ward who does not know the mouthwash solution and then stomatitis checklist is completed. |