The effect of vaginal product of roses on clinical symptoms in patients with cervicitis and If the effect of rosemary oil on cervicitis treatment is proven by this plan, it may be possible to formulate and prepare a vaginal drug for this traditional medicine product and introduce a new drug for the treatment of patients.
Design
Patients will be randomly assigned to either of the two groups of rosacea oil and standard drug treatment for cervicitis.
Settings and conduct
This study will be a clinical trial on 52 patients with Cervicitis who referred to the Women's Clinic of Shahid Sadoughi Hospital of Yazd. In the first group, patients will be treated with rose oil for two weeks, 3cc per night of drug content, and in the second group, standard drug therapy will be used in the treatment of cervicitis.The patient will return for two weeks to complete the treatment to reassess and evaluate the therapeutic response. If the patient does not recover, the gynecologist will receive routine medical treatment.
Participants/Inclusion and exclusion criteria
52 married women aged 17-55 years will be included in the study with diagnosis of cervicitis and if they are not pregnant and breastfeeding, with no history of cervical polyps and pelvic surgery and no concurrent use of herbal or chemical medication after obtaining informed consent.
Intervention groups
The first group of patients treated with rose oil
The second group is standard drug use in the treatment of cervicitis
Main outcome variables
Irritation;Itching;Discharge;Pain after intercourse;Post intercourse bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190810044500N1
Registration date:2020-03-29, 1399/01/10
Registration timing:registered_while_recruiting
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-16, 1398/09/25
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rose extract (Rosa damascena ) on sesame oil base in women with cervicitis
Public title
''The effect of Rose oil in women with cervicitis''
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 17-55 years with a diagnosis of cervicit based on the opinion of a gynecologist
Consent to participate in the study
Exclusion criteria:
Non-pregnancy and lactation
No history of cervical polyps and pelvic surgery
No simultaneous use of herbal or other chemicals
Age
From 17 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The composition of the studied drug has been extracted from authentic sources of Iranian traditional medicine.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
insitutional research Ethics Committee school of medicine - shahid sadoughi university of medical sc
Street address
yazd- yazd-shohaday gomnam blvd-shahid sadoughi university of medical sciences
City
yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.195
Health conditions studied
1
Description of health condition studied
Cervicit
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
Primary outcomes
1
Description
Mean of Wound size
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Clinical examination
2
Description
Mean of Wound depth
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Clinical examination
Secondary outcomes
1
Description
The amount of discharge
Timepoint
Before intervention, after intervention
Method of measurement
Clinical examination and patient based on VAS criteria
2
Description
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: Patients treated with rose oil for two weeks will be given 3 ml of drug content every night.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic of Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Zahra Dosthosseini
Street address
No. 59,Farhad Alley, Navab Safavi Boulevard
City
Yazd
Province
Yazd
Postal code
8918836986
Phone
+98 35 3528 0048
Email
doost.fatemeh74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Ave
City
Yazd
Province
Yazd
Postal code
9856783459
Phone
+98 35 3146 2056
Email
mmirzaei@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
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Dosthosseini
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 59, Farhad Alley , Safavi Boulevard
City
Yazd
Province
Yazd
Postal code
8918836986
Phone
+98 35 3528 0048
Email
doost.fatemeh74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme saghafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
yazd- yazd-shohaday gomnam blvd-shahid sadoughi university of medical sciences
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
Saghfi.Fa@gmail.comhs
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Dosthosseini
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 59, Farhad Alley , Safavi Boulevard
City
Yazd
Province
Yazd
Postal code
8918836986
Phone
+98 35 3528 0048
Email
doost.fatemeh74@gmail.com
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