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IRCT20170918036261N1 IRCT 2017-11-28 Vice chancellor for research Babol University of Medical Sciences The effect of yarrow vaginal cream on treatment of candida vaginitis The comparision effect of Achillea millefolium products on traditional medicine base, with clotrimazole cream 1% on vaginal candidiasis. 2017-12-22 anticipated 70 Complete https://irct.ir/trial/27161 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization in this study is quadruple blocking method and the randomization unit is individual and tool is statistical software. The sequencing will be done by quadruple blocking. Concealing done by using simillar form and size tubes for both groups, and neither the interventions nor the volunteers nor the data analyzer knows how to allocate the intervention, Blinding description: In this study, patients are completely unaware of which drugs they received. Also, the investigator and data analyzer are completely unaware that the two groups received which drug. 2-3 Candida vulvovaginitis. Intervention 1: Intervention group: Vaginal cream 2% of aqueous extract of Achillea millefolium, one applicator at night for 7 nights. Made in Pharmacy Department of Traditional Medicine, College of Traditional Medicine, Babol University of Medical Science. Intervention 2: Control group: Vaginal cream of clotrimazol 1% made by the PARS DAROU pharmaceutical company; Tehran, IRAN. One applicator at night for 7 nights. Undecided - It is not yet known if there will be a plan to make this available

public Somaye Zakerii

Babol Traditional Medicine College, Babol Univesity of Medical Sciences, Ganjafrooz Street, Karwgar Squar, Babol

Babol Iran (Islamic Republic of) 46159-73899 +98 11 4308 3172 www.drzakerii@yahoo.com Babol Univesity of Medical Sciences scientific Doctor Nargess Gorji

Babol Traditional Medicine college, Babol University of Medical Sciences, Ganjafrooz street, Karegar Square

Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11321995926 www.nargess_girji@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) married women,18 to 45 years old The presence of sign and symptoms of candida vulvovaginitis Positive smear from vaginal discharge for candida Positive culture of vaginal discharge for candida 18 years 45 years Female History of allergy to clotrimazole vaginal cream History of drug allergy Pregnancy Mensturation period Breastfeeding Menopause The presence of chronic underlying diseases: kidney, liver and Heart diseases, Diabetes and Immune deficiency Score 24-30 based on DLQI questionnaire Vulvar erythem score 3 Use of systemic antibiotics, immunosuppressive drugs or other vaginal creams and antifungal drugs during the past 4 weeks Patient's unsatisfactory to participate in the study B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention group: Vaginal cream 2% of aqueous extract of Achillea millefolium, one applicator at night for 7 nights. Made in Pharmacy Department of Traditional Medicine, College of Traditional Medicine, Babol University of Medical Science Control group: Vaginal cream of clotrimazol 1% made by the PARS DAROU pharmaceutical company; Tehran, IRAN. One applicator at night for 7 nights. Burning. Timepoint: At first, 7-10 days after the beginning of interventon and 2-3 weeks after the end of intervention. Method of measurement: Evauation of clinical symptom's remission (burning) with Dermatology Quality of Life Index (DLQI ) questionnaire. Pruritus. Timepoint: At first, 7-10 days after the begining of interventon and 2-3 weeks after the end of intervention. Method of measurement: Evauation of clinical symptom's remission (pruritus) with Dermatology Quality of Life Index (DLQI ) questionnaire. Dysparonia. Timepoint: At first, 7-10days after the begining of interventon and 2-3 weeks at the end of intervention. Method of measurement: Evauation the rate of satisfactory from intercourse with Dermatology Quality of Life Index (DLQI ) questionnaire. Volvar erythema. Timepoint: At first, 7-10days after the begining of interventon and 2-3 weeks at the end of intervention. Method of measurement: Vulvar examination and scoring the erythema of vulva by Gynecologist. Result of culture. Timepoint: At first, 7-10 days after the begining of intervention and 2-3 weeks after the end of intervention. Method of measurement: Sampling from vaginal discharges. Vice chancellor for research Babol University of Medical Sciences Approved 2017-08-27 Ethics committee of Babol University of Medical Science karegar squar., Ganjafrooz street., Babol University of Medical Science., Babol Babol Mazandaran Iran (Islamic Republic of)