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Comparison the effect of Origanum vulgare vaginal cream with clotrimazole vaginal cream on treatment of vulvovaginal candidiasis in reproductive aged women

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History
# Registration date Revision Id
5 2026-08-15, 1405/05/24 391655
4 2025-08-11, 1404/05/20 351488
3 2025-04-26, 1404/02/06 337597
2 2025-03-31, 1404/01/11 334939
1 2024-12-25, 1403/10/05 324861
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  • Protocol summary

    Result of direct microscopic and culture of vaginal discharge test and clinical symptoms of vulvovaginal candidiasis
    Clinical and laboratory indicators of vulvovaginal candidiasis
    نتیجه تست مشاهده مستقیم و کشت ترشحات واژن و علایم بالینی ولوواژینیت کاندیدایی
    شاخص‌های بالینی و آزمایشگاهی ولوواژینیت کاندیدایی

  • General information

    Amendment of the time points for assessing the outcome variables of complete recovery from vulvovaginal candidiasis and side effects
    This update was undertaken to complete, clarify, and organize the pre-specified variables documented in the study protocol; ensure precise and complete alignment of the timing of the follow-up assessments conducted with the information registered in the IRCT; provide additional information regarding the source and site of preparation of the vaginal creams used in the study; and make certain editorial and grammatical revisions to the registered information. These revisions were made solely to enhance transparency, complete the registered information, and ensure consistency between the registered documentation and the methodology actually implemented in the study, and do not involve any changes to the nature of the study, the type of intervention, the study groups, or the primary study procedures.
    اصلاح مقاطع زمانی اندازه گیری متغیرهای پیامد بهبودی کامل ولوواژینیت کاندیدایی و عوارض جانبی
    این به‌روزرسانی با هدف تکمیل، شفاف‌سازی و سامان‌دهی متغیرهای از پیش گردآوری‌شده در پروتکل مطالعه، تطبیق دقیق و کامل زمان‌بندی پیگیری‌های انجام‌شده با مستندات ثبت‌شده درIRCT، تکمیل اطلاعات مربوط به منبع تهیه و محل ساخت کرم‌های واژینال مورد استفاده در مطالعه و اعمال برخی اصلاحات نگارشی و ویرایشی در اطلاعات ثبت‌شده انجام شده است. این اصلاحات صرفاً با هدف افزایش شفافیت، تکمیل اطلاعات و انطباق مستندات ثبت‌شده با روش‌شناسی واقعی اجراشده در مطالعه صورت گرفته‌اند و هیچ‌گونه تغییری در ماهیت مطالعه، نوع مداخله، گروه‌های مطالعه یا روش اصلی اجرای پژوهش ایجاد نمی‌کنند.

  • Primary outcomes

    #1
    Vulvovaginal itching
    Composite clinical-mycological status of vulvovaginal candidiasis
    خارش ولوواژینال
    وضعیت ترکیبی بالینی-میکولوژیک ولوواژینیت کاندیدایی
    Before the intervention and one week after completing the treatment course
    2 weeks after the intervention
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    2 هفته پس از مداخله
    Taking the patient's history
    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)
    گرفتن شرح حال از بیمار
    گرفتن شرح حال از بیمار، معاینه بالینی، رنگ آمیزی گرم اسمیر ترشحات واژن و کشت ترشحات واژن بر روی محیط کشت کروم آگار کاندیدا (رفع کامل علائم و نشانه‌های اختصاصی ولوواژینیت کاندیدایی همراه با منفی بودن اسمیر مستقیم و کشت ترشحات واژن از نظر گونه‌های کاندیدا)
    #2
    Vulvovaginal erythema
    empty
    اریتم ولوواژینال
    empty
    Before the intervention and one week after completing the treatment course
    empty
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    empty
    Clinical examination
    empty
    معاینه بالینی
    empty
    #3
    Vulvovaginal burning
    empty
    سوزش ولوواژینال
    empty
    Before the intervention and one week after completing the treatment course
    empty
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    empty
    Taking the patient's history
    empty
    گرفتن شرح حال از بیمار
    empty
    #4
    Vaginal discharge
    empty
    ترشحات واژن
    empty
    Before the intervention and one week after completing the treatment course
    empty
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    empty
    Taking the patient's history and clinical examination
    empty
    گرفتن شرح حال از بیمار و معاینه بالینی
    empty
    #5
    Vaginal pH
    empty
    pH واژن
    empty
    Before the intervention and one week after completing the treatment course
    empty
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    empty
    pH indicator strips
    empty
    نوار pH سنج
    empty
    #6
    Gram staining of vaginal discharge smear test
    empty
    تست رنگ آمیزی گرم اسمیر ترشحات واژن
    empty
    Before the intervention and one week after completing the treatment course
    empty
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    empty
    Gram staining of vaginal discharge smear
    empty
    رنگ آمیزی گرم اسمیر ترشحات واژن
    empty
    #7
    Vaginal discharge culture
    empty
    کشت ترشحات واژن
    empty
    Before the intervention and one week after completing the treatment course
    empty
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    empty
    Vaginal discharge culture on CHROMagar candida medium
    empty
    کشت ترشحات واژن بر روی محیط کشت کروم آگار کاندیدا
    empty
    #8
    Complete recovery from vulvovaginal candidiasis
    empty
    بهبودی کامل ولوواژینیت کاندیدایی
    empty
    One week after completing the treatment course
    empty
    یک هفته پس از اتمام دوره درمان
    empty
    Taking the patient's history, clinical examination, Gram staining of vaginal discharge smear and vaginal discharge culture on CHROMagar candida medium
    empty
    گرفتن شرح حال از بیمار، معاینه بالینی، رنگ آمیزی گرم اسمیر ترشحات واژن و کشت ترشحات واژن بر روی محیط کشت کروم آگار کاندیدا
    empty

  • Secondary outcomes

    #1
    Urinary burning
    Vulvovaginal itching
    سوزش ادرار
    خارش ولوواژینال
    Before the intervention and one week after completing the treatment course
    Before the intervention, and 2 and 4 weeks after the intervention
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    قبل از مداخله، 2 و 4 هفته پس از مداخله
    Taking the patient's medical history
    In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit
    گرفتن شرح حال از بیمار
    گرفتن شرح حال حضوری از بیمار در ویزیت قبل از مداخله و پیگیری اول و گرفتن شرح حال تلفنی از بیمار در ویزیت پیگیری دوم
    #2
    Dyspareunia
    Vulvovaginal burning
    دیس پارونی
    سوزش ولوواژینال
    Before the intervention and one week after completing the treatment course
    Before the intervention, and 2 and 4 weeks after the intervention
    قبل از مداخله و یک هفته پس از اتمام دوره درمان
    قبل از مداخله، 2 و 4 هفته پس از مداخله
    Taking the patient's medical history
    In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit
    گرفتن شرح حال از بیمار
    گرفتن شرح حال حضوری از بیمار در ویزیت قبل از مداخله و پیگیری اول و گرفتن شرح حال تلفنی از بیمار در ویزیت پیگیری دوم
    #3
    Side effects
    Vulvovaginal irritation
    عوارض جانبی
    احساس ناراحتی و تحریک ولوواژینال
    One week after completing the treatment course
    Before the intervention, and 2 and 4 weeks after the intervention
    یک هفته پس از اتمام دوره درمان
    قبل از مداخله، 2 و 4 هفته پس از مداخله
    Taking the patient's medical history
    In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit
    گرفتن شرح حال از بیمار
    گرفتن شرح حال حضوری از بیمار در ویزیت قبل از مداخله و پیگیری اول و گرفتن شرح حال تلفنی از بیمار در ویزیت پیگیری دوم
    #4
    empty
    External dysuria
    empty
    سوزش خارجی هنگام دفع ادرار
    empty
    Before the intervention, and 2 and 4 weeks after the intervention
    empty
    قبل از مداخله، 2 و 4 هفته پس از مداخله
    empty
    In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit
    empty
    گرفتن شرح حال حضوری از بیمار در ویزیت قبل از مداخله و پیگیری اول و گرفتن شرح حال تلفنی از بیمار در ویزیت پیگیری دوم
    #5
    empty
    Dyspareunia
    empty
    درد هنگام نزدیکی
    empty
    Before the intervention, and 2 and 4 weeks after the intervention
    empty
    قبل از مداخله، 2 و 4 هفته پس از مداخله
    empty
    In-person history taking at pre-intervention and first follow-up visits and telephone history taking at the second follow-up visit
    empty
    گرفتن شرح حال حضوری از بیمار در ویزیت قبل از مداخله و پیگیری اول و گرفتن شرح حال تلفنی از بیمار در ویزیت پیگیری دوم
    #6
    empty
    Vulvovaginal erythema
    empty
    قرمزی ولوواژینال
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    Clinical examination
    empty
    معاینه بالینی
    #7
    empty
    Vulvovaginal edema
    empty
    ادم ولوواژینال
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    Clinical examination
    empty
    معاینه بالینی
    #8
    empty
    Curdy vaginal discharge
    empty
    ترشحات واژینال پنیری‌شکل
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    Clinical examination
    empty
    معاینه بالینی
    #9
    empty
    Vulvovaginal excoriation
    empty
    خراشیدگی ولوواژینال
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    Clinical examination
    empty
    معاینه بالینی
    #10
    empty
    Vaginal pH
    empty
    pH واژن
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    pH indicator strips
    empty
    نوار pH سنج
    #11
    empty
    Gram staining of vaginal discharge smear test
    empty
    تست رنگ آمیزی گرم اسمیر ترشحات واژن
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    Microscopic examination of a stained vaginal discharge smear for the presence of Candida species
    empty
    بررسی میکروسکوپی لام رنگ آمیزی شده ترشحات واژن از نظر وجود گونه‌های کاندیدا
    #12
    empty
    Vaginal discharge culture
    empty
    کشت ترشحات واژن
    empty
    Before the intervention and 2 weeks after the intervention
    empty
    قبل از مداخله و 2 هفته پس از مداخله
    empty
    Assessment of the vaginal discharge culture result on CHROMagar candida medium
    empty
    بررسی نتیجه کشت ترشحات واژن بر روی محیط کشت کروم آگار کاندیدا
    #13
    empty
    Side effects
    empty
    عوارض جانبی
    empty
    2 weeks after the intervention
    empty
    2 هفته پس از مداخله
    empty
    Patient history taking
    empty
    گرفتن شرح حال از بیمار
    #14
    empty
    Clinical recurrence
    empty
    عود بالینی
    empty
    4 weeks after the intervention
    empty
    4 هفته پس از مداخله
    empty
    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.
    empty
    گرفتن شرح حال تلفنی از بیمار در ویزیت پیگیری دوم به‌منظور بررسی بروز مجدد علائم اختصاصی ولوواژینیت کاندیدایی در بیمارانی که در ویزیت پیگیری اول، بهبودی کامل علائم و نشانه‌های بالینی ولوواژینیت کاندیدایی در آنان حاصل شده بود.

  • Intervention groups

    #1
    Intervention Group: In the intervention group, when administering the medication, necessary hygiene instructions will be provided to the patients. These instructions include: wearing cotton underwear and changing it regularly (at least every 1–2 days), washing the perineal area from front to back, drying it after washing and washing hands before and after using the medication. All participants in the intervention group will be instructed to use one full applicator (5 grams) of vaginal cream containing 0.2% Origanum vulgare essential oil every night for one week. They will also be advised to avoid using other vaginal medications, antibiotics, and engaging in unprotected intercourse during the treatment period. Finally, patients will be asked to return to the clinic for a post-treatment follow-up visit 7 days after completing the treatment course.
    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.
    گروه مداخله: در گروه مداخله، هنگام دادن دارو، دستورات بهداشتی لازم به بیماران ارائه خواهدشد که این دستورات شامل؛ استفاده از لباس زیر نخی و تعویض مرتب آن (حداقل2-1 روز یک بار)، شستشوی پرینه از قدام به خلف و نیز خشک کردن آن پس از شستشو و شستن دست ها قبل و بعد از استفاده از دارو میباشد. به تمامی افراد گروه مداخله گفته میشود که به مدت یک هفته، هر شب یک اپلیکاتور پر (5 گرم) کرم واژینال اسانس 0.2% گیاه پونه کوهی را مورد استفاده قرار دهند و از مصرف سایر داروهای واژینال و آنتی بیوتیک ها و مقاربت بدون کاندوم در طی دوره درمان خودداری نمایند. در نهایت از بیماران درخواست خواهد شد که 7 روز پس از کامل شدن دوره درمان، جهت پیگیری پس از درمان به درمانگاه مراجعه نمایند.
    گروه مداخله: در گروه مداخله، هنگام دادن دارو، دستورات بهداشتی لازم به بیماران ارائه می‌شود که این دستورات شامل؛ استفاده از لباس زیر نخی و تعویض مرتب آن (حداقل2-1 روز یک بار)، شستشوی پرینه از قدام به خلف و نیز خشک کردن آن پس از شستشو و شستن دست ها قبل و بعد از استفاده از دارو می‌باشد. به تمامی افراد گروه مداخله گفته می‌شود که به مدت یک هفته، هر شب یک اپلیکاتور پر (5 گرم) کرم واژینال اسانس 0.2% گیاه پونه کوهی (ساخته شده در مرکز تحقیقات گیاهان دارویی دانشگاه علوم پزشکی تهران) را مورد استفاده قرار دهند و از مصرف سایر داروهای واژینال و آنتی بیوتیک‌ها و مقاربت بدون کاندوم در طی دوره درمان خودداری نمایند. از بیماران درخواست می‌شود یک هفته پس از اتمام دوره درمان (پیگیری اول؛ معادل دو هفته پس از مداخله)، به‌منظور انجام پیگیری پس از درمان به درمانگاه مراجعه کنند. در بیمارانی که در پیگیری اول، تمامی علائم و نشانه‌های عفونت برطرف شده باشد، به‌منظور بررسی عود بالینی، سه هفته پس از اتمام دوره درمان (پیگیری دوم؛ معادل چهار هفته پس از مداخله)، پیگیری به‌صورت تلفنی انجام شده و علائم بالینی عفونت از طریق تماس تلفنی بررسی می‌شوند.
    #2
    Control Group: In the control group, when administering the medication, necessary hygiene instructions will be provided to the patients. These instructions include: wearing cotton underwear and changing it regularly (at least every 1–2 days), washing the perineal area from front to back, drying it after washing and washing hands before and after using the medication. All participants in the control group will be instructed to use one full applicator (5 grams) of 1% clotrimazole vaginal cream every night for one week. They will also be advised to avoid using other vaginal medications, antibiotics, and engaging in unprotected intercourse during the treatment period. Finally, patients will be asked to return to the clinic for a post-treatment follow-up visit 7 days after completing the treatment course.
    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.
    گروه کنترل: در گروه کنترل، هنگام دادن دارو، دستورات بهداشتی لازم به بیماران ارائه خواهدشد که این دستورات شامل؛ استفاده از لباس زیر نخی و تعویض مرتب آن (حداقل2-1 روز یک بار)، شستشوی پرینه از قدام به خلف و نیز خشک کردن آن پس از شستشو و شستن دست ها قبل و بعد از استفاده از دارو میباشد. به تمامی افراد گروه کنترل گفته میشود که به مدت یک هفته، هر شب یک اپلیکاتور پر (5 گرم) کرم واژینال کلوتریمازول 1% را مورد استفاده قرار دهند و از مصرف سایر داروهای واژینال و آنتی بیوتیک ها و مقاربت بدون کاندوم در طی دوره درمان خودداری نمایند. در نهایت از بیماران درخواست خواهد شد که 7 روز پس از کامل شدن دوره درمان، جهت پیگیری پس از درمان به درمانگاه مراجعه نمایند.
    گروه کنترل: در گروه کنترل، هنگام دادن دارو، دستورات بهداشتی لازم به بیماران ارائه خواهدشد که این دستورات شامل؛ استفاده از لباس زیر نخی و تعویض مرتب آن (حداقل2-1 روز یک بار)، شستشوی پرینه از قدام به خلف و نیز خشک کردن آن پس از شستشو و شستن دست ها قبل و بعد از استفاده از دارو میباشد. به تمامی افراد گروه کنترل گفته میشود که به مدت یک هفته، هر شب یک اپلیکاتور پر (5 گرم) کرم واژینال کلوتریمازول 1% (محصول شرکت پارس دارو) را مورد استفاده قرار دهند و از مصرف سایر داروهای واژینال و آنتی بیوتیک ها و مقاربت بدون کاندوم در طی دوره درمان خودداری نمایند. از بیماران درخواست می‌شود یک هفته پس از اتمام دوره درمان (پیگیری اول؛ معادل دو هفته پس از مداخله)، به‌منظور انجام پیگیری پس از درمان به درمانگاه مراجعه کنند. در بیمارانی که در پیگیری اول، تمامی علائم و نشانه‌های عفونت برطرف شده باشد، به‌منظور بررسی عود بالینی، سه هفته پس از اتمام دوره درمان (پیگیری دوم؛ معادل چهار هفته پس از مداخله)، پیگیری به‌صورت تلفنی انجام شده و علائم بالینی عفونت از طریق تماس تلفنی بررسی می‌شوند.

Protocol summary

Study aim
The aim of the present clinical trial is to compare the effectiveness of Origanum vulgare vaginal cream with clotrimazole vaginal cream on the treatment of vulvovaginal candidiasis.
Design
A phase 3 randomized clinical trial with a control group, parallel groups, triple-blind design, conducted on 98 patients. Randomization will be performed using permuted random blocks of sizes 4, 6, and 8, utilizing the website www.randomization.com.
Settings and conduct
This study will be a triple-blind, randomized controlled clinical trial conducted on 98 eligible women with vulvovaginal candidiasis who visit the sampling centers. In this study, participants will be randomly allocated using permuted block randomization with block sizes of 4, 6, and 8 into two groups: the control group (clotrimazole cream) and the intervention group (Origanum vulgare cream).
Participants/Inclusion and exclusion criteria
In this study, women aged 18 to 45 years with clinical symptoms of vulvovaginal candidiasis, positive results from direct microscopy and culture of vaginal discharge tests and no known sensitivity to Origanum vulgare or clotrimazole will be included. Pregnant and breastfeeding women, those with abnormal vaginal bleeding, known chronic diseases such as diabetes, hypertension and etc., recent use of broad-spectrum antibiotics or oral/vaginal medications related to genital infections within the past two weeks will be excluded from the study.
Intervention groups
Intervention Group: Vaginal cream containing 0.2% Origanum vulgare essential oil (one full applicator containing 5 grams of the vaginal cream every night for one week) Control Group: 1% clotrimazole vaginal cream (one full applicator containing 5 grams of the vaginal cream every night for one week)
Main outcome variables
Clinical and laboratory indicators of vulvovaginal candidiasis

General information

Reason for update
This update was undertaken to complete, clarify, and organize the pre-specified variables documented in the study protocol; ensure precise and complete alignment of the timing of the follow-up assessments conducted with the information registered in the IRCT; provide additional information regarding the source and site of preparation of the vaginal creams used in the study; and make certain editorial and grammatical revisions to the registered information. These revisions were made solely to enhance transparency, complete the registered information, and ensure consistency between the registered documentation and the methodology actually implemented in the study, and do not involve any changes to the nature of the study, the type of intervention, the study groups, or the primary study procedures.
Acronym
IRCT registration information
IRCT registration number: IRCT20241221064119N1
Registration date: 2024-12-25, 1403/10/05
Registration timing: prospective

Last update: 2026-08-17, 1405/05/26
Update count: 4
Registration date
2024-12-25, 1403/10/05
Registrant information
Name
Fatemeh Shahriari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 6521
Email address
shahriari.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-19, 1404/01/30
Expected recruitment end date
2025-07-21, 1404/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Origanum vulgare vaginal cream with clotrimazole vaginal cream on treatment of vulvovaginal candidiasis in reproductive aged women
Public title
Investigation the effect of Origanum vulgare vaginal cream on treatment of vulvovaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-12-07, 1403/09/17
Ethics committee reference number
IR.AJUMS.REC.1403.492

Health conditions studied

1

Description of health condition studied
Vulvovaginal candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina

Primary outcomes

1

Description
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)

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

6

Description
Vulvovaginal erythema
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Clinical examination

7

Description
Vulvovaginal edema
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Clinical examination

8

Description
Curdy vaginal discharge
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Clinical examination

9

Description
Vulvovaginal excoriation
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Clinical examination

10

Description
Vaginal pH
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
pH indicator strips

11

Description
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

12

Description
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

13

Description
Side effects
Timepoint
2 weeks after the intervention
Method of measurement
Patient history taking

14

Description
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.

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized obstetrics clinics of the affiliated hospitals of Ahvaz Jundishapur University
Full name of responsible person
Fatemeh Shahriari
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com

2

Recruitment center
Name of recruitment center
Comprehensive health services centers of west and east Ahvaz
Full name of responsible person
Fatemeh Shahriari
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Shahriari
Position
Master's student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Solmaz Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 9238
Email
sl.mohammadi89@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Shahriari
Position
Master's student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 634 9502
Email
fatemeh.shah9675@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be available for publication after the completion of the thesis and the publication of the article.
When the data will become available and for how long
One week after the completion of the thesis and the publication of the article.
To whom data/document is available
Ahvaz Jundishapur University of Medical Sciences and all researchers in hospitals, clinics and universities.
Under which criteria data/document could be used
The data will be accessible to others after analysis, through publication in scientific research journals.
From where data/document is obtainable
Fatemeh Shahriari, email: fatemeh.shah9675@gmail.com
What processes are involved for a request to access data/document
Requests can be sent via email, and a response will be provided within a maximum of one week to 10 days.
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