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IRCT2014012415860N1 IRCT 2014-01-24 School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with an artificial saliva in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with Hypozalix (artificial saliva) in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers 2014-02-20 anticipated 60 Complete https://irct.ir/trial/14996 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Radiation induced xerostomia. Intervention 1: Intervention group 1: Hypozalix 100 mL artificial saliva sprays, three times a day, every time two puffs, for 4 weeks. Intervention 2: Intervention group 2: Sachets of Malva sylvestris and Alcea digitata formulation, three times a day, each time one sachet into a cup of boiling water, stirred, and after cooling, drink it. For 4 weeks.
public Ghazaleh Heydarirad M.D
No.8 Shams Alley, Opposite Sttree Tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) +98 218877352 dr.ghazalrad@sbmu.ac.ir School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh scientific Ahmad Ameri M.D
Imam Hossein Hospital, Nezam Abad, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 7755 8081 aham47@yahoo.com Department of Radiation Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Scien Iran (Islamic Republic of) Inclusion criteria: xerostomia at least grade 1 based on clinical grading CTC; adverse event 4; age between 20 to 70 years old; physically and mentally able to fill out a questionnaire; willingness to participate in the study and informed consent; at least three months after the end of radiotherapy; not drinking alcohol; drugs affecting the salivary glands like antidepressant, opioids, antihypertensive, antihistamines, diuretics, all kind of mouthwash and artificial saliva; no history of connective tissue disease like Sjogren, rheumatoid arthritis, lupus, liver disease, kidney disease, major depression, diseases involving salivary glands, diabetes, chronic diseases such as diarrhea cause dehydration; the absence ofneutropenia, immunosuppression, myelosuppression Exclusion criteria: sudden changes in systemic conditions like that a patient requires extensive chemotherapy and surgical interventions; failure/ need parenteral nutrition (TPN) or hospitalization; unwillingness to continue participation in the study. 20 years 70 years Both K11.7 Dry mouth, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: Hypozalix 100 mL artificial saliva sprays, three times a day, every time two puffs, for 4 weeks. Intervention group 2: Sachets of Malva sylvestris and Alcea digitata formulation, three times a day, each time one sachet into a cup of boiling water, stirred, and after cooling, drink it. For 4 weeks. Xerostomia. Timepoint: Before interventin & weeks 2 and 4 after intervention. Method of measurement: VAS scale (determined by Question from patient) & Xerostomia Grade (determined by clinical examination). Quality of life. Timepoint: Before interventin and 4 weeks after intervention. Method of measurement: EORTC questionnaire. Other Symptoms. Timepoint: Before interventin and 4 weeks after intervention. Method of measurement: Question from patient. School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes Approved 2013-12-01 Office of Research Affairs, Deputy of Research and Technology, Shahid Beheshti University of Medical Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh St., Yemen St., Shahid Chamran Highway. Tehran Iran (Islamic Republic of)