Comparison of the effect of Hypericum perforutum Vaginal gel and Clotrimazole Vaginal cream on Vaginal Candida albicans infection: A double-blind randomized clinical trial
Determining and comparing the effects of Hypericum perforutum vaginal gel and clotrimazole vaginal cream on vaginal Candida albicans infection
Design
This is a randomized, double-blind, controlled clinical trial. which has a parallel group and will be performed on 80 patients with inclusion criteria. Random block method is used for randomization.
Settings and conduct
The research environment will be Shahid Mofateh Clinic in Yasuj city.The service provider screens the patients along with the gynecologist. For the final confirmation of the diagnosis, a serological test will be taken from the vaginal secretions. Only the pharmacist knows the type of drug used, and the researcher and service provider, the out come assessor and analyst, and the patient will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Women of reproductive age (18-49)
2- Presence of cheesy vaginal discharge and doctor's confirmation
3- Complaints of burning, itching and swelling and pain in the vulva and vagina
Exclusion criteria:
1- Lactating women
2- Pregnant women
3- Women who smoke
4- The possibility of starting menstruation in the next 10 days
5- Having intercourse in the last 24 hours
6- Washing the vagina and using vaginal medicine in the last 48 hours
8- History of candida vaginitis
Intervention groups
The intervention group includes women who presented with complaints of candida vaginitis symptoms and after the final diagnosis through clinical symptoms and serological tests, Hypericum perforutum vaginal cream therapeutic intervention will be performed on them.
Main outcome variables
Itching، Burning، the pain، Inflammation، Cheesy secretions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231017059753N1
Registration date:2023-12-20, 1402/09/29
Registration timing:registered_while_recruiting
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
leila bozorgian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 0240
Email address
liela.bozorgian1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Hypericum perforutum Vaginal gel and Clotrimazole Vaginal cream on Vaginal Candida albicans infection: A double-blind randomized clinical trial
Public title
Comparison of the effect of Hypericum perforutum Vaginal gel and Clotrimazole Vaginal cream on Vaginal Candida albicans infection: A double-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Women of reproductive age (18-49)-
2- Presence of cheesy vaginal discharge and doctor's confirmation
3- Complaints of burning, itching and swelling and pain in the vulva and vagina
4- Absence of other vaginal infections
5- Willingness to participate in the study
6- Women with sexual partners
Exclusion criteria:
1- Lactating women
2- Pregnant women
3- Women who smoke
4- The possibility of starting menstruation in the next 10 days
5- Having abnormal vaginal bleeding at the time of sampling
6- Having intercourse in the last 24 hours
7- Washing the vagina and using vaginal medicine in the last 48 hours
8- Having a history of any type of transplantation and using immunosuppressive drugs and broad-spectrum antibiotics, hormonal drugs and combined contraceptive pills, anti prostaglandins and anticoagulant drugs in the last month, and antiepileptic and migraine drugs or women with Heart and kidney diseases or sexually transmitted diseases.
9- History of Candida infection in the last 6 months and its treatment
10- History of candidal vaginitis
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be in the form of random block sampling based on the purpose and according to the study entry criteria. We consider the block size to be 5. Therefore, based on the sample size, we will have 20 blocks. When sampling starts, the first block will be randomly assigned one of the codes A or B. Based on the received code of the first block, the second code will be sent to the second block, the first code will be sent to the third block, the second code will be sent to the fourth block, and so on until the end of the 20th block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Hypericum perforutum vaginal gel and Clotrimazole vaginal cream have already been compared by the pharmacist in terms of appearance, color, size, smell and coded (A and B). The researcher, the service provider, the data analyst and the patient are unaware of the type of drug used, and only the pharmacist will be aware of this coding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari St., Yasouj University of Medical Sciences, Research Assistant
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2023-10-31, 1402/08/09
Ethics committee reference number
IR.YUMS.REC.1402.132
Health conditions studied
1
Description of health condition studied
Candida vaginitis
ICD-10 code
N76.1
ICD-10 code description
Subacute and chronic vaginitis
Primary outcomes
1
Description
Itching
Timepoint
Results will be measured ten days to two weeks after the end of the treatment period.
Method of measurement
The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms
2
Description
Burning
Timepoint
Results will be measured ten days to two weeks after the end of the treatment period.
Method of measurement
The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms
3
Description
vaginal pain
Timepoint
Results will be measured ten days to two weeks after the end of the treatment period.
Method of measurement
The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms.
4
Description
Inflammation
Timepoint
Results will be measured ten days to two weeks after the end of the treatment period.
Method of measurement
The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms.
5
Description
Cheesy secretions
Timepoint
Results will be measured ten days to two weeks after the end of the treatment period.
Method of measurement
The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms.
Secondary outcomes
1
Description
Satisfaction with treatment
Timepoint
One week to ten days after the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
The intervention group will use the vaginal gel of gerbera prepared by the pharmacist with a concentration of 3%. After manufacturing, it is poured into sterilized tubes and placed in a box with 5 applicators. Each applicator contains 5 grams of cream, which the patient is instructed to use every night for 5 nights. Explanations regarding not using other drugs and antibiotics and not using vaginal douche and other vaginal drugs during the treatment period will be given to the intervention group.
Category
Treatment - Drugs
2
Description
Control group: The control group will be clotrimazole vaginal cream. Tubes of Clotrimazole Vaginal Cream and Calendula Gel will match in terms of color, smell, size and shape. Each applicator contains 5 grams of cream, which the patient is instructed to use every night for 5 nights. Explanations regarding not using other drugs and antibiotics and not using vaginal douche and other vaginal drugs during the treatment period will be given to the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
15 Golestan St, Shahid Moftah Clinic، Yasuj
Full name of responsible person
Leila Bozorgian
Street address
Shahid Jalil St., Educational Campus, Medicinal Plants Research Center
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 0240
Email
liela.bozorgian1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Sayed Amin Hosseini motlagh
Street address
Shahid Jalil Street, Educational Campus
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 0240
Email
liela.bozorgian1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
2
Sponsor
Name of organization / entity
Vice President of Research and Technology of Yasouj University of Medical Sciences
Full name of responsible person
Dr. Sayed Amin Hosseini motlagh
Street address
Yasouj, Shahid Motahari St., Yasouj University of Medical Sciences, Deputy of research and technology
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3344 3931
Fax
+98 74 3344 4511
Email
sisacohortpersian@gmail.com
Web page address
http://cohort.yums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research and Technology of Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Leila Bozorgian
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Jalil Street, Educational Campus
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 0240
Email
liela.bozorgian1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Leila Bozorgian
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Jalil Street, Educational Campus
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 0240
Email
liela.bozorgian1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Leila Bozorgian
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Jalil Street, Educational Campus
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 0240
Email
liela.bozorgian1@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