Determining and comparing the effects of jujube vaginal cream and clotrimazole vaginal cream on vaginal candidiasis in women of reproductive age
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial of 74 eligible women with purposive vaginal candidiasis.
Settings and conduct
The research units will be eligible women with vaginal candidiasis who refer to health care center No. 2 in Mashhad. At the beginning of the study and after 7 days of using the vaginal cream, a vaginal secretion culture test will be performed.
Participants/Inclusion and exclusion criteria
Written consent to participate in the study; have minimum literacy, resident of Mashhad; married and age range 15-49; absence, no use of special medicine in the last two weeks; no allergy to clotrimazole and jujube; no pregnancy or breastfeeding; no use of IUD and hormonal contraceptive method; no recurrent vulvovaginitis candidiasis; no use of oral and topical antifungal (vaginal candidiasis treatment); at least a score of 3 from the total score of symptoms of vaginal candidiasis Bell (according to the questionnaire) and a positive test answer from the candidate's point of view.
Conditions of non-entry: occurrence of pregnancy; forgetting the medicine more than once; allergy to the given medicine; use of other antifungals; monthly habit during the study period; intimacy without using a condom and withdrawal of participation in the research by the research unit.
Intervention groups
The intervention group is treated with 3% jujube vaginal cream and 1% clotrimazole every night for one week, and the control group is treated with 1% clotrimazole vaginal cream every night for one week.
Main outcome variables
Treatment success Percent
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221002056076N1
Registration date:2023-08-01, 1402/05/10
Registration timing:prospective
Last update:2023-08-01, 1402/05/10
Update count:0
Registration date
2023-08-01, 1402/05/10
Registrant information
Name
Shima Bahadori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 677 9412
Email address
bahadoris982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effects of jujube vaginal cream and Clotrimazole cream on vaginal Candidiasis in women of reproductive age
Public title
Investigating and comparing the effects of jujube vaginal cream and clotrimazole cream on vaginal candidiasis infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent to participate in the study
Have minimum literacy
Resident of Mashhad
Married and age range 15-49
Absence, no use of special medicine in the last two weeks
No allergy to clotrimazole and jujube
No pregnancy or breastfeeding
No use of IUD and hormonal contraceptive method
No recurrent vulvovaginitis candidiasis
No use of oral and topical antifungal (vaginal candidiasis treatment)
At least a score of 3 from the total score of symptoms of vaginal candidiasis Bell (according to the questionnaire)
Positive test answer from the candidate's point of view
Exclusion criteria:
Occurrence of pregnancy
Forgetting medication more than once
Allergy to given medication
Use of other antifungals
Monthly habit during the study period
Intimacy without using condom
Withdrawal from participation in the research by the research unit
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done by the goal-based method and random allocation will be done through blocks of four using the random number table of www.randomization.com site in two groups (intervention and control). The method of concealment will be the allocation of closed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the jujube vaginal cream and Clotrimazole 1% cream in terms of size, color and smell, they are completely similar and the same tubes are provided to the researcher. Hertiop has a code that the pharmacist consultant is aware of. People who are eligible to enter the study are placed in groups according to the codes and using the table of random numbers. Therefore, until the end of the study, the participant and the researcher will not know about the codes related to Anab vaginal cream and Clotrimazole 1% cream.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street, Doctor's Crossroad, Ibn Sina Street, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.054
Health conditions studied
1
Description of health condition studied
Vaginal candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginal candidiasis
Timepoint
One week ± 24 hours
Method of measurement
Culture of vaginal secretions in the laboratory
Secondary outcomes
1
Description
Itching
Timepoint
Before treatment, one week ± 24 hours after treatment
Method of measurement
Patient history
2
Description
Erythema
Timepoint
Before treatment, one week ± 24 hours after treatment
Method of measurement
Patient history
3
Description
Burning
Timepoint
Before treatment, one week ± 24 hours after treatment
Method of measurement
Patient history
4
Description
Dys paranoia
Timepoint
Before treatment, one week ± 24 hours after treatment
Method of measurement
Patient history
5
Description
The result of the culture of vaginal secretions
Timepoint
Before treatment, one week ± 24 hours after treatment
Method of measurement
Patient history
Intervention groups
1
Description
For one week, treated with 3% jujube vaginal cream and 1% clotrimazole, one applicator every night
Category
Treatment - Drugs
2
Description
Control group: treated with clotrimazole 1% vaginal cream, one applicator every night for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center number two
Full name of responsible person
Ali Asghar Mahmoudi
Street address
next to Vahdat Park, Vahdat Boulevard, Panjarah Down Street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۵٣٩١٣١۵٣
Phone
+98 51 3368 3000
Email
M2HCenter@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
University Research and Technology Vice-Chancellor, Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Bahadri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
bahadoris928@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Erfanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ErfanianF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Bahadri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
bahadoris928@mums.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