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Randomize comparison of Vaginal suppository containing zhumeria majdae essential oil with vaginal clotrimazole versus placebo vaginal suppository with vaginal clotrimazole for vulvovaginal candidiasis treatment

Protocol summary

Study aim
Randomize comparison of vaginal suppository containing Zhumeria majdae essential oil with vaginal Clotrimazole versus placebo vaginal suppository with vaginal Clotrimazole for vulvovaginal candidiasis treatment
Design
This study is a single blind randomized parallel clinical trial
Settings and conduct
This study will perform in gharazi medical Clinic in malayer
Participants/Inclusion and exclusion criteria
Inclusion criterias : Women aged 18 to 50 years, married, lack of sensitivity to Zhumeria majdae, lack of sensitivity to Clotrimazole, signature of consent form to participate in the study, Diagnosis of vaginal candidiasis infection Exclusion criterias : Pregnancy and lactation, Menopause, Underlying diseases, Forgetting a dose or more, Patient unwillingness to continue treatment, Menstruation during the study, Abnormal uterine bleeding, Sensitivity to Zhumeria majdae, Sensitivity to clotrimazole
Intervention groups
1) Zhumeria majdae suppository 2)placebo suppository
Main outcome variables
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: IRCT20150706023084N12
Registration date: 2021-10-22, 1400/07/30
Registration timing: registered_while_recruiting

Last update: 2021-10-22, 1400/07/30
Update count: 0
Registration date
2021-10-22, 1400/07/30
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
2021-10-05, 1400/07/13
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomize comparison of Vaginal suppository containing zhumeria majdae essential oil with vaginal clotrimazole versus placebo vaginal suppository with vaginal clotrimazole for vulvovaginal candidiasis treatment
Public title
Randomize comparison of Vaginal suppository containing zhumeria majdae essential oil with vaginal clotrimazole versus placebo vaginal suppository with vaginal clotrimazole for vulvovaginal candidiasis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women aged 18 to 50 years Married lack of sensitivity to the plant compounds of Zhumeria majdae lack of sensitivity to clotrimazole signature the consent form to participate in the study Exclusioncriteria Diagnosis of vaginal candidiasis infection
Exclusion criteria:
pregnancy and lactation menopause underlyingdiseases forgetting a dose or more patientunwillingness to continue treatme menstruation during the study abnormal uterine bleeding sensitivity to Zhumeria majdae sensitivity to clotrimazole
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
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Vaginal suppositories of Zhumeria majdae and placebo were made by the researcher and placed in aluminum foils individually, and everyone except the researcher was unaware of the drug composition.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Medical Sciences, Tehran, Pharmacy and Pharmaceutical Sciences branches
Street address
Islamic azad University of Medical Sciences , Pharmacy and Pharmaceutical Sciences Branch , Yakhchal St., Gholhak, Dr. Shariati St. Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.IAU.PS.REC.1399.168

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 -Complete a checklist to evaluate the symptoms of candidal vaginitis and then compare thefrequency of symptoms of candidal vaginitis within and between the two treatment groups.

2

Description
discharge
Timepoint
Start of study - 7 days after the start of the study
Method of measurement
Questionnaire

3

Description
inflammation
Timepoint
Start of study - 7 days after the start of the study
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: It consists of 30 people, each of whom receives a 2-gram vaginal suppository containing 0.1 cc of Zhumeria maidae essential oil along with clotrimazole suppository every night for seven nights. Made in Tehran. Participants will be explained how to use the drug at the beginning of the study
Category
Treatment - Drugs

2

Description
Control group:It consists of 30 people, each of whom receives a 2-gram placebo suppository with clotrimazole suppository every night for seven nights. The user will be explained at the beginning of the study how to use the drug.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gharazi Clinic in Malayer
Full name of responsible person
Sepideh Kermani
Street address
Shokoofeh Alley, Nobahar St., Sepah Square
City
Malayer
Province
Hamadan
Postal code
6571945546
Phone
+98 81 3334 5700
Email
drskermani43@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Farshad Hashemian
Street address
Islamic azad university of medical science, Khaghani street, Dr Shariati street, Tehran
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
Sepideh Kermani
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shokoofeh Alley, Nobahar St., Sepah Square
City
Malayer
Province
Hamadan
Postal code
۶۵۷۱۹۴۵۵۴۶
Phone
+98 81 3334 5700
Email
drskermani43@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sepideh Kermani
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shokoofeh Alley, Nobahar St., Sepah Square
City
Malayer
Province
Hamadan
Postal code
6571945546
Phone
+98 81 3334 5700
Email
drskermani43@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Maryam Shiee Morteza
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University of pharmaceutical sciences Branch,Yakhchal St, Gholhak, Dr. Shariati St
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
ir.ac.iaups@shiehmorteza

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
Not applicable
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