Evaluation of the effectiveness of vaginal suppository containing coriander seed essential oil in comparison with clotrimazole suppository in the treatment of vaginal candidiasis
Design
This study is a single blind randomized parallel clinical trial
Settings and conduct
This study was performed in Imam Ali Educational and Medical Clinic in Shahrekord
Participants/Inclusion and exclusion criteria
Inclusion criteria: women aged 18 to 50 years,. Marriage, lack of sensitivity to the plant compounds of coriander seeds, lack of sensitivity to clotrimazole, signing the consent form to participate in the study
Exclusion criteria: pregnancy and lactation, menopause, underlying diseases, forgetting a dose or more, patient unwillingness to continue treatment, menstruation during the study, abnormal uterine bleeding
1) Symptoms of candidal vaginitis (including: itching, burning, vaginal redness, inflammation, vaginal discharge) 2) Symptoms of candidal vaginitis (including: vaginal erythema, white cheesy discharge and inflammation) 3) Possible side effects of drugs in both groups Therapies are compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N8
Registration date:2021-01-16, 1399/10/27
Registration timing:retrospective
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
2020-08-27, 1399/06/06
Actual recruitment end date
2020-12-20, 1399/09/30
Trial completion date
2020-12-27, 1399/10/07
Scientific title
In vivo evaluation of vaginal suppository containing Corianderum sativum essential oil effect on the treatment of candidiasis infection
Public title
In vivo evaluation of vaginal suppository containing corianderum sativum essential oil effect on the treatment of candidiasis infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18-50
Diagnosis of candidiasis infection
Signature of consent
Exclusion criteria:
Pregnancy, lactation, menopause, underlying diseases
Sex during the study
Forget a dose or more of medication
Allergy to clotrimazole or coriander suppository
The patient's unwillingness to continue treatment
Age
From 18 years old to 50 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Vaginal suppositories of coriander seeds were made by the researcher and placed in aluminum foils individually, and clotrimazole suppositories were removed from the main cover and placed in the foil, and everyone except the researcher was unaware of the drug composition.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic azad tehran medical sciences university-pharmacy and pharmaceutical branches faculty
Street address
No.47, shahid Rajaee St ,Shahr-e kord
City
Shahr-e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874459
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.IAU.PS.REC.1398.293
Health conditions studied
1
Description of health condition studied
candidiasis vulvovaginit
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Primary outcomes
1
Description
itching
Timepoint
Start of study - 7 days after the start of the study
Method of measurement
Questionnaire three-Complete a checklist to evaluate the symptoms of candidal vaginitis and then compare the frequency of symptoms of candidal vaginitis within and between the two treatment groups.
2
Description
discharge
Timepoint
Beginning of the study - 7 days after the start of the study
Method of measurement
Questionnaire three
3
Description
inflammation
Timepoint
Beginning of the study - 7 days after the start of the study
Method of measurement
Questionnaire three
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: consists of 30 people who each receive a 2 g vaginal suppository containing 0.1 cc of coriander seed essential oil every night for seven nights. This suppository is based on polyethylene glycol 1000 and 4000 at the rate of 75% and 25% in Shahrekord University of Medical Sciences. Participants were explained how to use the drug at the beginning of the study.
Category
Treatment - Drugs
2
Description
Control group: including 30 people who each receive a 500 mg clotrimazole vaginal suppository every night for seven nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic in Shahrekord
Full name of responsible person
Rahil Mokhtarian
Street address
No.47, Shahid Rajaee st
City
Shahr-e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874459
Phone
+98 38 3334 5449
Email
rahilm7466summer@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Farshad Hashemian
Street address
Dr shariati street, Khaghani street, Tehran islamic azad university of medical science
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
info@iau.ac.ir
Web page address
http://iaups.iautmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahil Mokhtarian
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No.47, Shahid Rajaee St
City
Shahr-e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874459
Phone
+98 38 3334 5449
Email
rahilm7466summer@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahil Mokhtarian
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No.47,Shahid Rajaee St.
City
Shahr-e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874459
Phone
+98 38 3334 5449
Email
rahilm7466summer@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiee Morteza
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr shariati street, Gholhak, Yakhchal street, Islamic azad university of pharmaceutical sciences Branch
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
shiehmorteza@iaups.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