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IRCT20191106045356N12 IRCT 2022-08-14 Yazd University of Medical Sciences Evaluation of the effects of thymol vaginal cream on bacterial vulvovaginitis Evaluation of the effectiveness of Thymol vaginal cream on improving symptoms in patients with bacterial vulvovaginitis; A double-blind randomized clinical trial 2022-08-23 anticipated 60 Complete https://irct.ir/trial/65205 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization (patients will be selected in blocks of 5) Randomization Unit: Person Randomization tool: Sealed envelopes To concealing random allocation will use Sequentially numbered, sealed, opaque envelopes (SNOSE), Blinding description: The study will be done in a double-blind manner. Patients, clinical caregiver (doctor) and evaluator (doctor) will not know about the intervention. Worms will be provided to the caregiver and the patient in identical boxes with numbers one and two written on them. 2-3 Bacterial vulvovaginitis (Trichomonas vaginalis). Intervention 1: Intervention group: patients with bacterial vulvovaginitis treated with topical thymol vaginal cream 5 mg, every night for up to one week. Intervention 2: Control group: Patients with bacterial vulvovaginitis treated with metronidazole 500 mg tablets twice a day for up to one week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohsen Zabihi
Prof. Hessabi Ave.
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3724 1171 mzabihi100@gmail.com Yazd University of Medical Sciences scientific Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) 891678477 +98 35 3820 3865 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Female Married Patients with bacterial vulvovaginitis based on ASMEL criteria Willingness to participate in the study and complete the ethical consent form 18 years 50 years Female Irritation or allergic reaction to the drug Aggravation of symptoms caused by infection Not taking medicine for more than one day Women who are pregnant, breastfeeding, have immune deficiency or malignancy History of mental disorders and psychosis Allergic reactions following consumption of thymol or products containing thymol A59.01 Trichomonal vulvovaginitis Treatment - Drugs Treatment - Drugs Intervention group: patients with bacterial vulvovaginitis treated with topical thymol vaginal cream 5 mg, every night for up to one week. Control group: Patients with bacterial vulvovaginitis treated with metronidazole 500 mg tablets twice a day for up to one week Complaints and clinical observations. Timepoint: Evaluation of complaints and clinical observations on days 1, 3 and 7 days after starting the use of thymol vaginal cream. Method of measurement: Likert scale. Clinical observations and complaints. Timepoint: At the beginning of the study and after days 1, 3 and 7 days after starting to use the vaginal cream. Method of measurement: Likert scale. Yazd University of Medical Sciences Approved 2020-03-10 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Prof. Hessabi Ave. Yazd Yazd Iran (Islamic Republic of)