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IRCT20241221064119N1 IRCT 2024-12-25 Ahvaz University of Medical Sciences Investigation the effect of Origanum vulgare vaginal cream on treatment of vulvovaginal candidiasis Comparison the effect of Origanum vulgare vaginal cream with clotrimazole vaginal cream on treatment of vulvovaginal candidiasis in reproductive aged women 2025-04-19 anticipated 98 Complete https://irct.ir/trial/80849 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the method of permuted block randomization to randomly assign participants to the intervention and control groups. The block sizes in this two-group clinical trial will be set at 4, 6, and 8 (in this method, the number of participants assigned to each group within a block is equal). To ensure allocation concealment, we will use random allocation concealment, which refers to the method used to implement the random sequence for participants in the study, such that the assigned group is not known before allocation. In this study, 1% clotrimazole vaginal cream, under sterile conditions, will be filled into tubes identical to those used for Origanum vulgare vaginal cream. These medications will be labeled as A and B by a pharmacist. Thus, the clotrimazole and Origanum vulgare vaginal creams will be identical in appearance, such as packaging and color, ensuring that neither the researcher nor the patient is aware of the type of vaginal cream being administered. The medications used in this study will be placed in sealed envelopes and assigned to each participant according to the randomized list by an individual not involved in the study, Blinding description: This study will be conducted in a triple-blind manner, meaning that the researcher, the study participants, and the data analyst (statistician) will all be completely unaware of the type of vaginal medication being used by the participants. Clotrimazole and Origanum vulgare vaginal creams will be dispensed into identical tubes and labeled as A and B by the pharmacist. Thus, the clotrimazole and Origanum vulgare vaginal creams will be identical in appearance, including packaging and color. The medications used in this study will be placed in sealed envelopes and assigned to each participant according to a randomized list prepared by an individual outside the study. 3 Vulvovaginal candidiasis. Intervention 1: Intervention group: In the intervention group, patients are provided with the necessary hygiene instructions at the time of medication administration. These instructions include wearing cotton underwear and changing it regularly (at least once every 1–2 days), washing the perineal area from front to back and drying it after washing, and washing the hands before and after applying the medication. All participants in the intervention group are instructed to use one full applicator (5 g) of 0.2% oregano essential oil vaginal cream (prepared at the Medicinal Plants Research Center, Tehran University of Medical Sciences) every night for one week and to refrain from using other vaginal medications, antibiotics, and unprotected sexual intercourse during the treatment period. Patients are asked to attend the clinic one week after completion of the treatment course (first follow-up; equivalent to two weeks after the intervention) for post-treatment follow-up. In patients in whom all signs and symptoms of the infection have resolved at the first follow-up, a telephone follow-up is conducted three weeks after completion of the treatment course (second follow-up; equivalent to four weeks after the intervention) to assess clinical recurrence, and the clinical symptoms of infection are assessed by telephone. Intervention 2: Control group: In the control group, patients will be provided with the necessary hygiene instructions at the time of medication administration. These instructions include wearing cotton underwear and changing it regularly (at least once every 1–2 days), washing the perineal area from front to back and drying it after washing, and washing the hands before and after applying the medication. All participants in the control group will be instructed to use one full applicator (5 g) of 1% clotrimazole vaginal cream (manufactured by Pars Darou Company) every night for one week and to refrain from using other vaginal medications, antibiotics, and unprotected sexual intercourse during the treatment period. Patients will be asked to attend the clinic one week after completion of the treatment course (first follow-up; equivalent to two weeks after the intervention) for post-treatment follow-up. In patients in whom all signs and symptoms of the infection have resolved at the first follow-up, a telephone follow-up will be conducted three weeks after completion of the treatment course (second follow-up; equivalent to four weeks after the intervention) to assess clinical recurrence, and the clinical symptoms of infection will be assessed by telephone. Yes - There is a plan to make this available What will be shared: The data will be available for publication after the completion of the thesis and the publication of the article. When: One week after the completion of the thesis and the publication of the article. To whom: Ahvaz Jundishapur University of Medical Sciences and all researchers in hospitals, clinics and universities. Conditions: The data will be accessible to others after analysis, through publication in scientific research journals. Where to obtain: Fatemeh Shahriari, email: fatemeh.shah9675@gmail.com How to obtain: Requests can be sent via email, and a response will be provided within a maximum of one week to 10 days. Comments:
public Fatemeh Shahriari
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 916 634 9502 fatemeh.shah9675@gmail.com Ahvaz University of Medical Sciences scientific Solmaz Mohammadi
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3320 9238 sl.mohammadi89@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being married Being monogamous The presence of clinical symptoms indicative of vulvovaginal candidiasis Positive result of the direct microscopy test of vaginal discharge Positive result of the vaginal discharge culture test No history of any known medical condition No allergy to Origanum vulgare plant and clotrimazole Completion of a written informed consent form 18 years 45 years Female Pregnancy Breastfeeding Menopause Abnormal vaginal bleeding Body mass index (BMI) ≥ 30 History of recurrent vulvovaginal candidiasis infections (4 or more episodes per year) History of known chronic diseases such as diabetes, hypertension, heart disease, immune system disorders and epilepsy Use of broad-spectrum antibiotics within the past two weeks Use of immunosuppressive drugs, corticosteroids or contraceptive pills Use of oral or vaginal medications related to genital infections within the past two weeks B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, patients are provided with the necessary hygiene instructions at the time of medication administration. These instructions include wearing cotton underwear and changing it regularly (at least once every 1–2 days), washing the perineal area from front to back and drying it after washing, and washing the hands before and after applying the medication. All participants in the intervention group are instructed to use one full applicator (5 g) of 0.2% oregano essential oil vaginal cream (prepared at the Medicinal Plants Research Center, Tehran University of Medical Sciences) every night for one week and to refrain from using other vaginal medications, antibiotics, and unprotected sexual intercourse during the treatment period. Patients are asked to attend the clinic one week after completion of the treatment course (first follow-up; equivalent to two weeks after the intervention) for post-treatment follow-up. In patients in whom all signs and symptoms of the infection have resolved at the first follow-up, a telephone follow-up is conducted three weeks after completion of the treatment course (second follow-up; equivalent to four weeks after the intervention) to assess clinical recurrence, and the clinical symptoms of infection are assessed by telephone. Control group: In the control group, patients will be provided with the necessary hygiene instructions at the time of medication administration. These instructions include wearing cotton underwear and changing it regularly (at least once every 1–2 days), washing the perineal area from front to back and drying it after washing, and washing the hands before and after applying the medication. All participants in the control group will be instructed to use one full applicator (5 g) of 1% clotrimazole vaginal cream (manufactured by Pars Darou Company) every night for one week and to refrain from using other vaginal medications, antibiotics, and unprotected sexual intercourse during the treatment period. Patients will be asked to attend the clinic one week after completion of the treatment course (first follow-up; equivalent to two weeks after the intervention) for post-treatment follow-up. In patients in whom all signs and symptoms of the infection have resolved at the first follow-up, a telephone follow-up will be conducted three weeks after completion of the treatment course (second follow-up; equivalent to four weeks after the intervention) to assess clinical recurrence, and the clinical symptoms of infection will be assessed by telephone. Composite clinical-mycological status of vulvovaginal candidiasis. Timepoint: 2 weeks after the intervention. Method of measurement: Taking the patient's history, clinical examination, Gram staining of vaginal discharge smear and vaginal discharge culture on CHROMagar candida medium (complete resolution of the specific clinical signs and symptoms of vulvovaginal candidiasis, together with a negative direct smear and vaginal discharge culture for Candida species). Vulvovaginal itching. Timepoint: Before the intervention, and 2 and 4 weeks after the intervention. Method of measurement: In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit. Vulvovaginal burning. Timepoint: Before the intervention, and 2 and 4 weeks after the intervention. Method of measurement: In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit. Vulvovaginal irritation. Timepoint: Before the intervention, and 2 and 4 weeks after the intervention. Method of measurement: In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit. External dysuria. Timepoint: Before the intervention, and 2 and 4 weeks after the intervention. Method of measurement: In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit. Dyspareunia. Timepoint: Before the intervention, and 2 and 4 weeks after the intervention. Method of measurement: In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit. Vulvovaginal erythema. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Clinical examination. Vulvovaginal edema. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Clinical examination. Curdy vaginal discharge. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Clinical examination. Vulvovaginal excoriation. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Clinical examination. Vaginal pH. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: pH indicator strips. Gram staining of vaginal discharge smear test. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Microscopic examination of a stained vaginal discharge smear for the presence of Candida species. Vaginal discharge culture. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Assessment of the vaginal discharge culture result on CHROMagar candida medium. Side effects. Timepoint: 2 weeks after the intervention. Method of measurement: Patient history taking. Clinical recurrence. Timepoint: 4 weeks after the intervention. Method of measurement: Telephone follow-up at the second follow-up visit to assess the recurrence of specific symptoms of vulvovaginal candidiasis in patients who had achieved a complete clinical cure of the signs and symptoms of vulvovaginal candidiasis at the first follow-up visit. Ahvaz University of Medical Sciences Approved 2024-12-07 The ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)