History
# Registration date Revision Id
4 2024-02-13, 1402/11/24 299111
3 2023-12-08, 1402/09/17 287832
2 2023-11-27, 1402/09/06 287011
1 2021-07-13, 1400/04/22 190150
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  • General information

    82
    92
    empty
    Since the sampling was done during the COVID-19 crisis and the possibility of further loss of patients in the process، we increased the number of patients.
    empty
    از انجایی که بیماریابی در زمان بحران بیماری کووید19 انجام می شد و احتمال ریزش بیشتر بیماران در روند کار داده شد، تعداد بیماران را افزایش دادیم.
    Effect of vaginal suppository of Henna oil based in cervicitis treatment
    Effect of Henna vaginal suppository in the treatment of cervicitis
    بررسی اثر شیاف واژینال روغن حنا در سرویسیت
    اثر شیاف واژینال حنا در درمان سرویسیت
    Comparison the efficacy of oral Azithromycin, Cefixime and Metronidazole with vaginal suppository of Henna (Lawsonia inermis) oil based in women with cervicitis
    The effect of Henna (Lawsonia inermis) vaginal suppository in the treatment of cervicitis : A Randomized Triple-blind Clinical Trial
    مقایسه اثربخشی درمان خوراکی آزیترومایسین، سفیکسیم و مترونیدازول با شیاف واژینال روغن حنا در زنان مبتلا به سرویسیت
    تاثیر شیاف واژینال حنا در درمان سرویسیت: کارآزمایی بالینی تصادفی سه سوکور
    Married women over the age of 21 and premenopausal who for any reason have indicated colposcopy and biopsy, such as refractory vaginal discharge, spotting after intercourse or menstruation, abnormal Pap smear, or abnormal appearance of the cervix on examination with a speculum. Colposcopy and biopsy were performed and only cervicitis was reported and no warts, dysplasia or cancers.
    Willingness and satisfaction to participate in the study
    Patients who have only one sexual partner and are the only sexual partner of the desired spouse.
    married women aged over 21 and non menopause who confirme cervicitis through colposcopy and biopsy with symptoms such as refractory vaginal discharge, postcoital bleeding (PCB), abnormal uterine bleeding (AUB), abnormal Pap smear, or abnormal appearance of the cervix on examination with a speculum.
    زنان متاهل با سن بالای 21 سال و پره منوپوز که به هر علتی که اندیکاسیون کولپوسکوپی و بیوپسی داشته اند مانند ترشحات واژینال مقاوم به درمان، لکه بینی بعد از نزدیکی یا بین قاعدگی، پاپ اسمیر غیرطبیعی و یا ظاهر غیرطبیعی سرویکس در معاینه با اسپکولوم تحت کولپوسکوپی و بیوپسی قرار گرفته بودند و صرفا سرویسیت گزارش شده و زگیل، دیسپلازی و کنسر ندارند.
    تمایل و رضایت شرکت در مطالعه
    بیمارانی که تنها یک شریک جنسی دارند و خودشان تنها شریک جنسی همسر مورد نظر هستند.
    زنان متاهل با سن بالای 21 سال و غیریائسه که به هر علتی که اندیکاسیون کولپوسکوپی و بیوپسی داشته اند مانند ترشحات واژینال مقاوم به درمان، لکه بینی بعد از نزدیکی یا بین قاعدگی، پاپ اسمیر غیرطبیعی و یا ظاهر غیرطبیعی سرویکس در معاینه با اسپکولوم تحت کولپوسکوپی و بیوپسی قرار میگیرند و صرفا سرویسیت گزارش می شود.
    Menopause
    Pregnancy
    Breastfeeding
    Having any addiction
    Observe herpes sores or genital warts on examination and/or HPV positive test
    Use of antibiotics or herbal remedies for her illness (has not taken any antibiotics, immunosuppressive drugs or vaginal medications in the 14 days before the study).
    History of allergies to henna and olive oil
    being pregnant
    lactating
    involved in any addiction
    observing herpes sores or genital warts on examination and/or HPV positive test
    dysplasia or cancer of cervix
    intake of herbal products or medications that influence cervicitis like antibiotics, immunosuppressive drugs or vaginal medications over 2 weeks before the commencement of the study
    history of allergies to Henna
    patients with possible side effects, who will not complete the treatment
    patients who will decide to withdraw from the study for personal reasons
    یائسگی
    حاملگی
    شیردهی
    ابتلا به هرگونه اعتیاد
    مشاهده زخم های هرپسی یا زگیل تناسلی در معاینه و یا تستHPVمثبت
    مصرف همزمان داروهای آنتی بیوتیک یا گیاهی جهت بیماری خود( طی 14 روز قبل از مطالعه آنتی بیوتیک، داروهای مضعف کننده سیستم ایمنی و یا داروهای واژینالی مصرف نکرده باشند).
    سابقه وجود حساسیت به حنا و روغن زیتون
    حاملگی
    شیردهی
    ابتلا به هرگونه اعتیاد
    مشاهده زخم های هرپسی یا زگیل تناسلی در معاینه و یا تستHPVمثبت
    دیسپلازی یا کنسر سرویکس
    مصرف فراورده های گیاهی یا داروهایی که در سرویسیت اثر می گذارد مثل آنتی بیوتیک ها، داروهای مضعف کننده سیستم ایمنی یا داروهای واژینال طی 14 روز قبل از شروع مطالعه
    سابقه وجود حساسیت به حنا
    بیماران با عوارض احتمالی که مطالعه را ادامه نمی دهند
    بیمارانی که به دلایل شخصی تمایل به خروج از مطالعه را دارند
  • Primary outcomes

    #1
    The amount of discharge
    Mean of Wound size
    میزان ترشحات
    اندازه زخم سرویکس
    Clinical examination and patient based on VAS criteria
    Clinical examination
    معاینه بالینی بیمار و بر اساس معیار VAS
    معاینه بالینی بیمار
  • Secondary outcomes

    #1
    Mean of Wound size
    Vaginal discharges
    اندازه زخم سرویکس
    ترشحات واژینال
    Clinical examination
    Visual Analogue Scale
    معاینه بالینی
    Visual Analogue Scale
    #2
    Adnexal tenderness
    Irritation
    حساسیت آدنکس
    سوزش
    Clinical examination
    Visual Analogue Scale
    معاینه بالینی
    Visual Analogue Scale
    #3
    Irritation
    Dyspareunia
    سوزش
    درد حین نزدیکی
    VAS criterion
    Yes- no
    معیار VAS
    دارد- ندارد
    #4
    Itching
    Postcoital bleeding
    خارش
    خونریزی بعد از نزدیکی
    VAS criterion
    Yes- no
    معیار VAS
    دارد- ندارد
    #5
    Pain after intercourse
    Friability
    درد حین نزدیکی
    شکنندگی
    #6
    Post intercourse bleeding
    empty
    خونریزی بعد از نزدیکی
    empty
    Before intervention, after intervention
    empty
    قبل از مداخله، پس از اتمام مداخله
    empty
    Yes- no
    empty
    دارد- ندارد
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: Specialized Poly-Clinic Of Baghaei Pour
    Name of recruitment center - Persian: درمانگاه تخصصی وفوق تخصصی بقایی پور
    Full name of responsible person - English: naeeme nabi meybodi
    Full name of responsible person - Persian: نعیمه نبی میبدی
    Street address - English: Specialized Poly-Clinic Of Baghaei Pour, Shahid Ghandi Blvd, Safaieh, Yazd
    Street address - Persian: یزد، صفائیه، بلوار شهید قندی، پلی کلینیک تخصصی و فوق تخصصی هاشم بقائی پور
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915887857
    Phone: +98 35 3822 9105
    Fax:
    Email: baghaei@ssu.ac.ir
    Web page address:
    Name of recruitment center - English: Specialized Poly-Clinic Of Baghaei Pour
    Name of recruitment center - Persian: درمانگاه تخصصی وفوق تخصصی بقایی پور
    Full name of responsible person - English: Naeeme Nabi Meybodi
    Full name of responsible person - Persian: نعیمه نبی میبدی
    Street address - English: Specialized Poly-Clinic of Baghaei Pour, Shahid Ghandi Blvd, Safaieh, Yazd
    Street address - Persian: یزد، صفائیه، بلوار شهید قندی، پلی کلینیک تخصصی و فوق تخصصی هاشم بقائی پور
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8915887857
    Phone: +98 35 3822 9105
    Fax:
    Email: baghaei@ssu.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Ardakan School of Persian Medicine
    Name of recruitment center - Persian: دانشکده طب ایرانی اردکان
    Full name of responsible person - English: naeeme nabi meybodi
    Full name of responsible person - Persian: نعیمه نبی میبدی
    Street address - English: Ardakan School of Persian Medicine, Imam Khomeini Ave, Ardakan
    Street address - Persian: اردکان، خیابان امام خمینی، دانشکده طب ایرانی اردکان
    City - English: Ardakan
    City - Persian: اردکان
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8951737915
    Phone: +98 35 3723 8915
    Fax:
    Email: tebsonati@ssu.ac.ir
    Web page address:
    Name of recruitment center - English: Ardakan School of Persian Medicine
    Name of recruitment center - Persian: دانشکده طب ایرانی اردکان
    Full name of responsible person - English: Naeeme Nabi Meybodi
    Full name of responsible person - Persian: نعیمه نبی میبدی
    Street address - English: Ardakan School of Persian Medicine, Imam Khomeini Ave, Ardakan
    Street address - Persian: اردکان، خیابان امام خمینی، دانشکده طب ایرانی اردکان
    City - English: Ardakan
    City - Persian: اردکان
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8951737915
    Phone: +98 35 3723 8915
    Fax:
    Email: tebsonati@ssu.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Masoud Mirzaee
    Full name of responsible person - Persian: مسعود میرزایی
    Street address - English: Bahonar Square
    Street address - Persian: میدان باهنر
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۶۹۷۸۴۷۷
    Phone: +98 35 3724 0171
    Fax:
    Email: dvc.research@ssu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Masoud Mirzaee
    Full name of responsible person - Persian: مسعود میرزایی
    Street address - English: Yazd University of Medical Sciences, Bahonar Square
    Street address - Persian: میدان باهنر
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: dvc.research@ssu.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison the efficacy of oral Azithromycin, Cefixime and Metronidazole with vaginal suppository of Henna oil based in women with cervicitis
Design
This is a triple-blind randomized clinical trial, phase III, in which 82 eligible patients will be randomly assigned to the intervention and control groups.
Settings and conduct
Patients with cervicitis referred to Shahid Sadoughi Hospital in Yazd and Ardakan School of Persian Medicine will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups. This trial will be triple-blinded so that neither patients nor the examining physician nor statistical analysts will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 21 years and premenopausal; cervicitis; married. Exclusion criteria: menopause; pregnancy; breastfeeding; any addiction; observe herpes sores or genital warts on examination and/or HPV positive test; concomitant use of antibiotic or herbal remedies for her disease (do not take antibiotic, immunosuppressive drugs or vaginal medications for 14 days before study); history of allergies to henna and olive oil.
Intervention groups
Intervention group: Cefexime tab 400 mg single dose, azithromycin tab 1 mg single dose and metronidazole tab 500 mg every 12 hours for 5 days and vaginal suppository of Henna oil based every night for a week and couples treated with cefixime 400 mg single dose, azithromycin 1 mg single dose and 4 metronidazole 500 mg single dose. Control group: Cefexime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and basic suppository for 1 week, 1 each night and spouses similar to the intervention group.
Main outcome variables
Discharge; Irritation; Itching; Pain after intercourse; Post intercourse bleeding

General information

Reason for update
Since the sampling was done during the COVID-19 crisis and the possibility of further loss of patients in the process، we increased the number of patients.
Acronym
IRCT registration information
IRCT registration number: IRCT20210312050686N1
Registration date: 2021-07-13, 1400/04/22
Registration timing: prospective

Last update: 2023-12-01, 1402/09/10
Update count: 3
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
naeeme nabi meybodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 3995
Email address
n.nabimeybodi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Henna (Lawsonia inermis) vaginal suppository in the treatment of cervicitis : A Randomized Triple-blind Clinical Trial
Public title
Effect of Henna vaginal suppository in the treatment of cervicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
married women aged over 21 and non menopause who confirme cervicitis through colposcopy and biopsy with symptoms such as refractory vaginal discharge, postcoital bleeding (PCB), abnormal uterine bleeding (AUB), abnormal Pap smear, or abnormal appearance of the cervix on examination with a speculum.
Exclusion criteria:
being pregnant lactating involved in any addiction observing herpes sores or genital warts on examination and/or HPV positive test dysplasia or cancer of cervix intake of herbal products or medications that influence cervicitis like antibiotics, immunosuppressive drugs or vaginal medications over 2 weeks before the commencement of the study history of allergies to Henna patients with possible side effects, who will not complete the treatment patients who will decide to withdraw from the study for personal reasons
Age
From 21 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the intervention and control groups through random sequences generated by random allocation software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple-blind controlled clinical trial. The pharmacist identifies the drug and the placebo with two types of codes A and B. Researcher, patients, and statistical analysts do not know whether A or B is a drug or a placebo. Therefore, the researcher, patients and statistical analyst are kept blind until the end of the study. At each visit, patients are randomly assigned to group A or B. People will not know how to distribute the drug and the drugs are available to patients in opaque colored bottles with a similar shape and sealed according to the codes defined randomly. The tools and materials needed to make the placebo will be exactly the same as the medicine except that only the active ingredient is removed from the placebo.
Placebo
Used
Assignment
Parallel
Other design features
The effect of the studied drug has been extracted from reliable sources of traditional Iranian medicine.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Yazd University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-12-06, 1399/09/16
Ethics committee reference number
IR.SSU.REC.1399.193

Health conditions studied

1

Description of health condition studied
Cervicitis
ICD-10 code
Inflammato
ICD-10 code description
N72

Primary outcomes

1

Description
Mean of Wound size
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Clinical examination

Secondary outcomes

1

Description
Vaginal discharges
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Visual Analogue Scale

2

Description
Irritation
Timepoint
Before intervention, after intervention
Method of measurement
Visual Analogue Scale

3

Description
Dyspareunia
Timepoint
Before intervention, after intervention
Method of measurement
Yes- no

4

Description
Postcoital bleeding
Timepoint
Before intervention, after intervention
Method of measurement
Yes- no

5

Description
Friability
Timepoint
Before intervention, after intervention
Method of measurement
Yes- no

Intervention groups

1

Description
Intervention group: Cefixime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and vaginal suppository of Henna oil based every night for a week and partner cefixime 400 mg single dose, azithromycin 1 mg single dose and 4 metronidazole 500 mg
Category
Treatment - Drugs

2

Description
Control group: Cefixime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and placebo one every night for a week and partner Cefixime 400 mg single dose, Azithromycin 1 mg single dose and 4 metronidazole 500 mg
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Poly-Clinic Of Baghaei Pour
Full name of responsible person
Naeeme Nabi Meybodi
Street address
Specialized Poly-Clinic of Baghaei Pour, Shahid Ghandi Blvd, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 9105
Email
baghaei@ssu.ac.ir

2

Recruitment center
Name of recruitment center
Ardakan School of Persian Medicine
Full name of responsible person
Naeeme Nabi Meybodi
Street address
Ardakan School of Persian Medicine, Imam Khomeini Ave, Ardakan
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
tebsonati@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaee
Street address
Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Naeeme Nabi Meybodi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Yazd University of Medical Sciences, Bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Razieh Nabi Meybodi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
r.nabimeybodi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Naeeme Nabi Meybodi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Yazd University of Medical Sciences, Bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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