Comparison the efficacy of oral Azithromycin, Cefixime and Metronidazole with vaginal suppository of Henna (Lawsonia inermis) oil based in women with cervicitis
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
Acronym
IRCT registration information
IRCT registration number:IRCT20210312050686N1
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-13, 1400/04/22
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
Comparison the efficacy of oral Azithromycin, Cefixime and Metronidazole with vaginal suppository of Henna (Lawsonia inermis) oil based in women with cervicitis
Public title
Effect of vaginal suppository of Henna oil based in cervicitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
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:
82
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
Ethics committee of Yazd University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
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
The amount of discharge
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Clinical examination and patient based on VAS criteria
Secondary outcomes
1
Description
Mean of Wound size
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Clinical examination
2
Description
Adnexal tenderness
Timepoint
Before intervention, after intervention
Method of measurement
Clinical examination
3
Description
Irritation
Timepoint
Before intervention, after intervention
Method of measurement
VAS criterion
4
Description
Itching
Timepoint
Before intervention, after intervention
Method of measurement
VAS criterion
5
Description
Pain after intercourse
Timepoint
Before intervention, after intervention
Method of measurement
Yes- no
6
Description
Post intercourse bleeding
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
Bahonar Square
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
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