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Ethics committees
#1
2020-12-06, 1399/09/16
2020-10-27, 1399/08/06
2020-1210-0627 00:00:00
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:2023-12-09, 1402/09/18
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
2020-10-27, 1399/08/06
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