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IRCT201309253706N20 IRCT 2014-03-03 Research deputy of Tabriz University of Medical Sciences Effect of calendula officinalis on treatment of candida vaginitis Comparing calendula officinalis and clotrimazole for treatment of candida vaginitis: a randomized controlled trial 2014-03-03 anticipated 124 Complete https://irct.ir/trial/3811 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants and people involved in data collection, laboratory investigation and data analysis will be blinded of the subjects' group assignment. N/A Candida vaginitis. Intervention 1: Intervention I: vaginal use of Calendula Officinalis cream, one aplicator every night for 7 nights. Intervention 2: Intervention II: Vaginal use of Clotrimazole cream, one aplicator every night for 7 nights.
public Elnaz Saffari
Kousar Dormitory, South Shariati Ave, Tabriz
Tabriz Iran (Islamic Republic of) elnazsafari82@yahoo.com Midwifery Department, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347
Tabriz Iran (Islamic Republic of) alizades@tbzmed.ac.ir Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: aged 18 to 45 years old; being married; diagnosis of candidiasis; single sexual partner; no history of allergy to drugs and plants; being literate; giving consent to participate in the study. Exclusion criteria: having any known chronic disease; use of any antibiotics and corticosteroids in the past two weeks; receiving antifungal drugs in the past 4 weeks; currently taking oral contraceptives; existence of other vaginal infections; any sores or lumps at the cervix; experience of severe stress over the past month; known Pregnancy; lactation; currently use of other herbal medicines; participation at another trial. 18 years 45 years Female B37.3+ Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention I: vaginal use of Calendula Officinalis cream, one aplicator every night for 7 nights Intervention II: Vaginal use of Clotrimazole cream, one aplicator every night for 7 nights Response to the treatment. Timepoint: 10-15 days after the initiation of intervention. Method of measurement: Assessment of vaginal pH, direct observation, secretion culture. Relapse of the infection. Timepoint: 30-35 days after the initiation of intervention. Method of measurement: Assessment of vaginal pH, direct observation, secretion culture. Sexual function score. Timepoint: Before intervention, 30-35 days after the initation of therapy. Method of measurement: Female sexual function Index (FSFI). Adverse events. Timepoint: 10-15 days after the initation of therapy. Method of measurement: Self-report. Clinical complaints. Timepoint: Baseline, 10-15 and 30-35 days after initiation of intervention. Method of measurement: Self-report. Client satisfaction. Timepoint: 10-15 and 30-35 days after the initation of intervention. Method of measurement: Self-report. Research deputy of Tabriz University of Medical Sciences Approved 2014-02-10 Tabriz University of Medical Sciences, Research Deputy 3rd floor, Centeral building No 2, Tabriz University of Medical Sciences, Golgasht st., Tabriz Tabriz Iran (Islamic Republic of)