Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment of fungal and bacterial infections and wound healing and vaginal inflammations
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Protocol summary
After obtaining permission, the case group of 100 people and the control group of 100 people who have been proven to have vaginal infections will enter the study. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) in separate groups and only placebo was prescribed to the control group.
Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. which random number table was used for randomization. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) produced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and the control group was prescribed only placebo.
After obtaining permission, the case group of 100 people and theClinical trial with control group of, with parallel groups, single-blind, randomized, on 100 people who have been proven to have vaginal infections will enter the studypatients. which random number table was used for randomization. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test. Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) in separate groupsproduced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and only placebo was prescribed to the control group was prescribed only placebo.
پس از کسب مجوز گروه مورد 100 نفره با گروه شاهد 100نفره كه ابتلای آنها به عفونتهاي واژينال به اثبات رسیده است وارد مطالعه می شوند عفونتهاي واژينال قبل و بعد از مداخله با معاينه باليني توسط متخصص زنان و تست پاپ اسمير بررسي خواهد شد.
زمان گرفتن پاپ اسمير قبل از مداخله و 4 هفته بعد از درمان خواهدبود. به گروه مداخله کپسولهاي گياهي بلوط، انار، پنیرک و دارچین (هرشب يكي به صورت واژينال) در گروههاي جدا و گروه شاهد تنها پلاسبو تجويز ميگردد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 100 بیمار. که برای تصادفی سازی از جدول اعداد تصادفی استفاده شد. عفونتهاي واژينال قبل و بعد از مداخله با معاينه باليني توسط متخصص زنان و تست پاپ اسمير بررسي خواهد شد.
زمان گرفتن پاپ اسمير قبل از مداخله و 4 هفته بعد از درمان خواهدبود. به گروه مداخله کپسولهاي گياهي بلوط، انار، پنیرک و دارچین (هرشب يكي به صورت واژينال) محصول شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831، داده شد و گروه شاهد تنها پلاسبو تجويز ميگردد.
پس از کسب مجوزکارآزمایی بالینی دارای گروه مورد 100 نفرهکنترل، با گروه شاهد 100نفره كه ابتلای آنها به عفونتهاي واژينال به اثبات رسیده است وارد مطالعه می شوندهای موازی ، یک سویه کور ، تصادفی شده، بر روی 100 بیمار. که برای تصادفی سازی از جدول اعداد تصادفی استفاده شد. عفونتهاي واژينال قبل و بعد از مداخله با معاينه باليني توسط متخصص زنان و تست پاپ اسمير بررسي خواهد شد. زمان گرفتن پاپ اسمير قبل از مداخله و 4 هفته بعد از درمان خواهدبود. به گروه مداخله کپسولهاي گياهي بلوط، انار، پنیرک و دارچین (هرشب يكي به صورت واژينال) در گروههاي جدامحصول شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831، داده شد و گروه شاهد تنها پلاسبو تجويز ميگردد.
After obtaining permission, the case group of 100 people and the control group of 100 people who have been proven to have vaginal infections will enter the study. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) in separate groups and only placebo was prescribed to the control group.
Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. which random number table was used for randomization. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) produced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and the control group was prescribed only placebo.
After obtaining permission, the case group of 100 people and theClinical trial with control group of, with parallel groups, single-blind, randomized, on 100 people who have been proven to have vaginal infections will enter the studypatients. which random number table was used for randomization. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test. Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) in separate groupsproduced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and only placebo was prescribed to the control group was prescribed only placebo.
پس از کسب مجوز گروه مورد 100 نفره با گروه شاهد 100نفره كه ابتلای آنها به عفونتهاي واژينال به اثبات رسیده است وارد مطالعه می شوند عفونتهاي واژينال قبل و بعد از مداخله با معاينه باليني توسط متخصص زنان و تست پاپ اسمير بررسي خواهد شد.
زمان گرفتن پاپ اسمير قبل از مداخله و 4 هفته بعد از درمان خواهدبود. به گروه مداخله کپسولهاي گياهي بلوط، انار، پنیرک و دارچین (هرشب يكي به صورت واژينال) در گروههاي جدا و گروه شاهد تنها پلاسبو تجويز ميگردد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 100 بیمار. که برای تصادفی سازی از جدول اعداد تصادفی استفاده شد. عفونتهاي واژينال قبل و بعد از مداخله با معاينه باليني توسط متخصص زنان و تست پاپ اسمير بررسي خواهد شد.
زمان گرفتن پاپ اسمير قبل از مداخله و 4 هفته بعد از درمان خواهدبود. به گروه مداخله کپسولهاي گياهي بلوط، انار، پنیرک و دارچین (هرشب يكي به صورت واژينال) محصول شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831، داده شد و گروه شاهد تنها پلاسبو تجويز ميگردد.
پس از کسب مجوزکارآزمایی بالینی دارای گروه مورد 100 نفرهکنترل، با گروه شاهد 100نفره كه ابتلای آنها به عفونتهاي واژينال به اثبات رسیده است وارد مطالعه می شوندهای موازی ، یک سویه کور ، تصادفی شده، بر روی 100 بیمار. که برای تصادفی سازی از جدول اعداد تصادفی استفاده شد. عفونتهاي واژينال قبل و بعد از مداخله با معاينه باليني توسط متخصص زنان و تست پاپ اسمير بررسي خواهد شد. زمان گرفتن پاپ اسمير قبل از مداخله و 4 هفته بعد از درمان خواهدبود. به گروه مداخله کپسولهاي گياهي بلوط، انار، پنیرک و دارچین (هرشب يكي به صورت واژينال) در گروههاي جدامحصول شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831، داده شد و گروه شاهد تنها پلاسبو تجويز ميگردد.
The sample's vaginitis has been recorded by a gynecologist.
the age group of 20-50 years
be married
Inclusion criteria: samples were diagnosed with vaginitis by a gynecologist, age group 20-50 years, being married.
Do not enter: Allergy to herbal medicines
The sample'sInclusion criteria: samples were diagnosed with vaginitis has been recorded by a gynecologist. the, age group of 20-50 years be, being married. Do not enter: Allergy to herbal medicines
ابتلای نمونه ها به واژينيت توسط متخصص زنان
گروه سنی 50- 20 سال
متاهل
معیار ورود: ابتلای نمونه ها به واژينيت توسط متخصص زنان،گروه سنی 50- 20 سال، متاهل بودن
عدم ورود: حساسیت به داروهای گیاهی
معیار ورود: ابتلای نمونه ها به واژينيت توسط متخصص زنان،گروه سنی 50- 20 سال، متاهل بودن عدم ورود: حساسیت به داروهای گیاهی
There are 100 married women in Isfahan who refer to women's specialist clinic due to vaginal infections.
There are 100 married women who refer to women's specialist clinic due to vaginal infections.
There are 100 married women in Isfahan who refer to women's specialist clinic due to vaginal infections.
100 زنان متاهل اصفهان که به علت عفونتهاي واژينال به مطب متخصصين زنان مراجعه مينمايند.
100 زنان متاهل که به علت عفونتهاي واژينال به مطب متخصصين زنان مراجعه مينمايند.
100 زنان متاهل اصفهان که به علت عفونتهاي واژينال به مطب متخصصين زنان مراجعه مينمايند.
General information
Double blinded
Single blinded
doublsingl
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1
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Please, the name of the company that provides the drug to the researcher should be mentioned in the summary of the trial placed on the site
Please, the name of the company that provides the drug to the researcher should be mentioned in the summary of the trial placed on the site
empty
لطفا نام شرکتی که دارو را به محقق می دهد در خلاصه کارآزمایی قرار داده شده بر روی سایت ذکر گردد
لطفا نام شرکتی که دارو را به محقق می دهد در خلاصه کارآزمایی قرار داده شده بر روی سایت ذکر گردد
Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases.
They are taking chemical drugs for vaginitis.
Unwilling patients will be excluded from the study.
.Willingness to participate in the study
They have a vaginal infection
Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases. They are taking chemical drugs for vaginitis. Unwilling patients will be excluded fromWillingness to participate in the study. They have a vaginal infection
سابقه بيماريهاي تضعيف كننده سيستم ايمني ديابت،ياسايربيماريهاي متابوليكي را دارامی باشند.
در حال مصرف داروهاي شيميايي واژينيت هستند.
بیمارانی که عدم تمایل دارند از مطالعه خارج خواهند شد.
تمایل به شرکت در مطالعه
عفونت واژینال دارند
سابقه بيماريهاي تضعيف كننده سيستم ايمني ديابت،ياسايربيماريهاي متابوليكي را دارامی باشند.تمایل به شرکت در حال مصرف داروهاي شيميايي واژينيت هستند. بیمارانی که عدم تمایلمطالعه عفونت واژینال دارند از مطالعه خارج خواهند شد.
Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases
They are taking chemical drugs for vaginitis.
Unwilling patients will be excluded from the study
Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases They are taking chemical drugs for vaginitis. Unwilling patients will be excluded from the study
سابقه بيماريهاي تضعيف كننده سيستم ايمني ديابت،ياسايربيماريهاي متابوليكي را دارامی باشند.
در حال مصرف داروهاي شيميايي واژينيت هستند.
بیمارانی که عدم تمایل دارند از مطالعه خارج خواهند شد.
سابقه بيماريهاي تضعيف كننده سيستم ايمني ديابت،ياسايربيماريهاي متابوليكي را دارامی باشند. در حال مصرف داروهاي شيميايي واژينيت هستند. بیمارانی که عدم تمایل دارند از مطالعه خارج خواهند شد.
Patients were assigned to intervention and control groups by throwing a coin (line or lion).
In this study, a simple randomization model was used, using a lottery. In this way, 100 people who came to the office and met the entry criteria were assigned a number, then all the numbers were thrown into a ball and one person was selected by lottery. The intervention group and one person was assigned to the control group
PatientsIn this study, a simple randomization model was used, using a lottery. In this way, 100 people who came to the office and met the entry criteria were assigned toa number, then all the numbers were thrown into a ball and one person was selected by lottery. The intervention group and one person was assigned to the control groups by throwing a coin (line or lion).group
بیماران با انداختن سکه( خط یا شیر ) به گروه مداخله و کنترل تخصیص یافتند
در اين مطالعه از مدل تصادفي سازي ساده ، با استفاده از قرعه کشی استفاده شد.بدین ترتیب که به 100 نفری که به مطب مراجعه کرده و معیار ورود داشتند شماره تعلق گرفت سپس همه شماره ها در گوی ریخته شد و با قرعه کشی یک نفر به گروه مداخله و یک نفر به گروه شاهد اختصاص یافت
بیماراندر اين مطالعه از مدل تصادفي سازي ساده ، با انداختن سکه( خط یا شیر )استفاده از قرعه کشی استفاده شد.بدین ترتیب که به 100 نفری که به مطب مراجعه کرده و معیار ورود داشتند شماره تعلق گرفت سپس همه شماره ها در گوی ریخته شد و با قرعه کشی یک نفر به گروه مداخله و کنترل تخصیص یافتندیک نفر به گروه شاهد اختصاص یافت
The participants and the clinical caregiver did not know whether they were in the drug or placebo group
Participants do not know whether they are in the drug or placebo group. The herbal medicine is powdered and poured into a dark capsule cover, so that the contents cannot be seen. Placebo capsules are filled with dark colored flour. The participant does not know whether the capsule they are receiving is placebo or treatment.
The participants and the clinical caregiver didParticipants do not know whether they wereare in the drug or placebo group. The herbal medicine is powdered and poured into a dark capsule cover, so that the contents cannot be seen. Placebo capsules are filled with dark colored flour. The participant does not know whether the capsule they are receiving is placebo or treatment.
شرکت کنندگان و مراقب بالینی از اینکه در گروه دارو یا پلاسو هستند اطلاع نداشتند
شرکت کنندگان از اینکه در گروه دارو یا پلاسو هستند اطلاع ندارند. داروی گیاهی پودر شده و در جلد کپسول رنگ تیره ریخته می شود که محتویات دیده نمی شود. در کپسول پلاسبو هم به با جلد رنگ تیره آرد ریخته می شود. شرکت کننده نمی داند کپسولی که دریافت می کند پلاسبو یا درمان است.
شرکت کنندگان و مراقب بالینی از اینکه در گروه دارو یا پلاسو هستند اطلاع نداشتندندارند. داروی گیاهی پودر شده و در جلد کپسول رنگ تیره ریخته می شود که محتویات دیده نمی شود. در کپسول پلاسبو هم به با جلد رنگ تیره آرد ریخته می شود. شرکت کننده نمی داند کپسولی که دریافت می کند پلاسبو یا درمان است.
Primary outcomes
#1
inflammation
Inflammation
inflammationInflammation
Intervention groups
#1
Intervention group: In this study, "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Derman Mehsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, double-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 2014.
Intervention group: In this study, "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Darman Mahsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, single-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 2023.
Intervention group: In this study, "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Derman MehsanDarman Mahsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, doublesingle-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 20142023.
گروه مداخله: در این مطالعه تأثیر متغیر مستقل «مصرف کپسول حاوی عصاره گیاهی بلوط، انار، پنیرک و دارچین از شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831 بر متغیرهای وابسته عفونت های قارچی و باکتریایی و التهاب های واژینال درزنان بررسی می گردد و از طرفی مطالعه در گروههای شاهد و مورد انجام خواهد گردید و تخصیص گروه شاهد و مورد در آن بصورت اتفاقی بوده است، می باشد. اينکارآزمايي باليني،دو سوكور،كنترل بادارونما،و دوگروهي قبل و بعد برروي100 فرد مبتلا به عفونتهاي واژينال که به مطب متخصصين زنان شهر اصفهان در طی سال1402مراجعه خواهند نمود،انجام خواهدشد.
گروه مداخله: در این مطالعه تأثیر متغیر مستقل «مصرف کپسول حاوی عصاره گیاهی بلوط، انار، پنیرک و دارچین از شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831 بر متغیرهای وابسته عفونت های قارچی و باکتریایی و التهاب های واژینال درزنان بررسی می گردد و از طرفی مطالعه در گروههای شاهد و مورد انجام خواهد گردید و تخصیص گروه شاهد و مورد در آن بصورت اتفاقی بوده است، می باشد. اينکارآزمايي باليني،یک سوكور،كنترل بادارونما،و دوگروهي قبل و بعد برروي100 فرد مبتلا به عفونتهاي واژينال که به مطب متخصصين زنان شهر اصفهان در طی سال1402مراجعه خواهند نمود،انجام خواهدشد.
گروه مداخله: در این مطالعه تأثیر متغیر مستقل «مصرف کپسول حاوی عصاره گیاهی بلوط، انار، پنیرک و دارچین از شرکت دارو درمان مهسان نفیس با مسیولیت محدود به شماره ثبت 4831 بر متغیرهای وابسته عفونت های قارچی و باکتریایی و التهاب های واژینال درزنان بررسی می گردد و از طرفی مطالعه در گروههای شاهد و مورد انجام خواهد گردید و تخصیص گروه شاهد و مورد در آن بصورت اتفاقی بوده است، می باشد. اينکارآزمايي باليني،دویک سوكور،كنترل بادارونما،و دوگروهي قبل و بعد برروي100 فرد مبتلا به عفونتهاي واژينال که به مطب متخصصين زنان شهر اصفهان در طی سال1402مراجعه خواهند نمود،انجام خواهدشد.
Recruitment centers
#1
Name of recruitment center - English: Gynecologist's office
Name of recruitment center - Persian: مطب متخصص زنان
Full name of responsible person - English: maryam allahdadian
Full name of responsible person - Persian: مریم اله دادیانای
Street address - English: Falavarjan, Islamic Azad University
Street address - Persian: فلاورجان، دانشگاه آزاد اسلامی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8451731167
Phone: +98 31 3742 0134
Fax:
Email: maryamallahdadian@yahoo.com
Web page address: https://falavarjan.iau.ir/fa
Name of recruitment center - English: Gynecologist's office
Name of recruitment center - Persian: مطب متخصص زنان
Full name of responsible person - English: maryam allahdadian
Full name of responsible person - Persian: مریم اله دادیان
Street address - English: Basij Boulevard, Islamic Azad University, Falavarjan branch
Street address - Persian: دانشگاه آزاد اسلامی فلاورجان، بلوار بسیج
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8451731167
Phone: +98 31 3742 0134
Fax:
Email: maryamallahdadian@yahoo.com
Web page address: https://falavarjan.iau.ir/fa
Name of recruitment center - English: Gynecologist's office Name of recruitment center - Persian: مطب متخصص زنان Full name of responsible person - English: maryam allahdadian Full name of responsible person - Persian: مریم اله دادیانایدادیان Street address - English: FalavarjanBasij Boulevard, Islamic Azad University, Falavarjan branch Street address - Persian: فلاورجان، دانشگاه آزاد اسلامی فلاورجان، بلوار بسیج City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8451731167 Phone: +98 31 3742 0134 Fax: Email: maryamallahdadian@yahoo.com Web page address: https://falavarjan.iau.ir/fa
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: maryamallahdadian
Full name of responsible person - Persian: مریم اله دادیان
Street address - English: Falavarjan,Islamic Azad University
Street address - Persian: فلاورجان، دانشگاه آزاد اسلامی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8451731167
Phone: +98 31 3742 0134
Fax:
Email: maryamallahdadian@yahoo.com
Web page address: https://falavarjan.iau.ir/fa
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: maryamallahdadian
Full name of responsible person - Persian: مریم اله دادیان
Street address - English: Basij Boulevard, Islamic Azad University, Falavarjan branch
Street address - Persian: دانشگاه آزاد اسلامی فلاورجان، بلوار بسیج
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8451731167
Phone: +98 31 3742 0134
Fax:
Email: maryamallahdadian@yahoo.com
Web page address: https://falavarjan.iau.ir/fa
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: maryamallahdadian Full name of responsible person - Persian: مریم اله دادیان Street address - English: Falavarjan,IslamicBasij Boulevard, Islamic Azad University, Falavarjan branch Street address - Persian: فلاورجان، دانشگاه آزاد اسلامی فلاورجان، بلوار بسیج City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8451731167 Phone: +98 31 3742 0134 Fax: Email: maryamallahdadian@yahoo.com Web page address: https://falavarjan.iau.ir/fa
Mahsan Nafis Pharmaceutical Co., Ltd
Daru Darman Mahsan Nafis with limited responsibility by registration number 4831
Daru Darman Mahsan Nafis Pharmaceutical Co., Ltdwith limited responsibility by registration number 4831
Protocol summary
Study aim
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum herbal capsules on the treatment of fungal, bacterial infections and vaginal inflammations
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. which random number table was used for randomization. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) produced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and the control group was prescribed only placebo.
Settings and conduct
Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. which random number table was used for randomization. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) produced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and the control group was prescribed only placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: samples were diagnosed with vaginitis by a gynecologist, age group 20-50 years, being married.
Do not enter: Allergy to herbal medicines
Intervention groups
There are 100 married women who refer to women's specialist clinic due to vaginal infections.
Main outcome variables
Fungal infections، bacterial infections and inflammation
General information
Reason for update
Please, the name of the company that provides the drug to the researcher should be mentioned in the summary of the trial placed on the site
Acronym
IRCT registration information
IRCT registration number:IRCT20131110015349N4
Registration date:2023-06-11, 1402/03/21
Registration timing:registered_while_recruiting
Last update:2023-06-27, 1402/04/06
Update count:1
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Maryam Allahdadian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7140
Email address
allahdadian@iaufala.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment of fungal and bacterial infections and wound healing and vaginal inflammations
Public title
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment ofvaginal infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
.Willingness to participate in the study
They have a vaginal infection
Exclusion criteria:
Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases
They are taking chemical drugs for vaginitis.
Unwilling patients will be excluded from the study
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization model was used, using a lottery. In this way, 100 people who came to the office and met the entry criteria were assigned a number, then all the numbers were thrown into a ball and one person was selected by lottery. The intervention group and one person was assigned to the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know whether they are in the drug or placebo group. The herbal medicine is powdered and poured into a dark capsule cover, so that the contents cannot be seen. Placebo capsules are filled with dark colored flour. The participant does not know whether the capsule they are receiving is placebo or treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Najafaba Branch
Street address
University Boulevar, Islamic Azad University, Najaf Abad branch
City
Najafabad
Province
Isfehan
Postal code
851413131
Approval date
2022-09-29, 1401/07/07
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1401.121
Health conditions studied
1
Description of health condition studied
Inflammatory disease of cervix uteri
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
2
Description of health condition studied
Candidiasis of vulva and vagina
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
3
Description of health condition studied
Vaginitis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Inflammation
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Pap smear result
2
Description
Fungal infections
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Pap smear result
3
Description
Bacterial infection
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Pap smear result
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Darman Mahsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, single-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 2023.
Category
Treatment - Drugs
2
Description
Control group: In the control group, a pap smear was taken first, and then a placebo was given to the patient, and after one month the results of the pap smear were checked.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecologist's office
Full name of responsible person
maryam allahdadian
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Fax
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryamallahdadian
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Daru Darman Mahsan Nafis with limited responsibility by registration number 4831
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
confidentiality
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available