The aim of this study was the effect of vaginal cream zizyphus spina leave in the treatment of candidacies vulvovaginitis.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
Groups after the midwife are diagnosed with vaginitis in midwifery health centers and specialized clinics of Al-Hadi Hospital in Shoushtar will be randomly and double blind (researchers and Studied groups) divided into intervention and control groups. The intervention group will use vaginal cream zizyphus spina leave and the control group will use standard treatment of vaginal candidiasis, clotrimazole 1% vaginal cream.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate vaginitis signs and symptoms in interview or observation and confirmation by laboratory study; married women between 20-45 years old; patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse; Informed consent to participate in the study. Exclusion criteria: women who had used oral or topical antifungal drugs, corticosteroids and antibiotics 2 weeks before the study; Steroid medication use; IUD use; pregnancy; breast feeding; diabetes and immunodeficiency; Abnormal uterine bleeding; menstruation and side effects of the drug.
Intervention groups
group received Vaginal cream of zizyphus spina leave
Comparison of the effect of vaginal cream of zizyphus spina (sider) leave with clotrimazole vaginal cream on treatment of candidiasis vulvovaginitis
Public title
The effect of vaginal cream zizyphus spina(sider) leave in the treatment of candidacies vulvovaginitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Candidate vaginitis signs and symptoms in interview or observation and confirmation by laboratory study; married women between 20-45 years old; patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse; Informed consent to participate in the study.
Exclusion criteria:
Exclusion criteria: women who had used oral or topical antifungal drugs, corticosteroids and antibiotics 2 weeks before the study; Steroid medication use; IUD use; pregnancy; breast feeding; diabetes and immunodeficiency; Abnormal uterine bleeding; menstruation and side effects of the drug.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly divided into permutation blocks with the size of block 6. The drugs used in this study were randomly assigned by the out-of-study list to the corresponding codes in the closed envelopes and then assigned to each patient who entered the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ziziphus spina-christi green leaves vaginal cream was prepared by adding the extract to a suitable cream base (emulsion of water in oil) at concentrations of 5% . In the pharmacy, 1% of clotrimazole vaginal cream was prepared using the same base. All final products had the same appearance and an approved color was used to maintain uniformity. Microbiological and physicochemical tests (uniformity, physical stability, distribution, and acidity) were performed on the prepared formulations. Samples will be randomly assigned to A and B medication. Both Ziziphus spina-christi leaves vaginal cream and clotrimazole 1% can be used with applicators and are named A and B because the researcher and research units are unaware of them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shoushtar faculty of medical sciences
Street address
Shoushtar Faculty of Medical Sciences, Alhade hospital, Rajae BLV, Shoushtar
City
shoushtar
Province
Khouzestan
Postal code
64516-84534
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.SHOUSHTAR.REC.1398.008
Health conditions studied
1
Description of health condition studied
candidacies vulvovaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Compelet remission
Timepoint
7days and 14 days after treatment
Method of measurement
Evaluation of clinical symptom's remission with questionnaire
2
Description
Vaginal Culture Results
Timepoint
Before and 7 Day After intervention
Method of measurement
Esmear Vaginal
3
Description
Vaginal pH
Timepoint
Before and 7 day After intervention
Method of measurement
By pH meter strips
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:vaginal cream of zizyphus spina (sider) leave once applicator a day for 1 week
Category
Treatment - Drugs
2
Description
Control group: Clotrimazole vaginal cream once applicator a day for 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers and the Specialized Clinic of Al-Hadi Hospital in Shuoshtar
Full name of responsible person
Azam Honarmandpour
Street address
Shoushtar Faculty of Medical Sciences. Alhadi Hospital. Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 9544
Email
navarbaf_n@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shoushtar Faculty of Medical Sciences
Full name of responsible person
Deputy Research and technology Shoushtar Faculty of Medical Sciences
Street address
Shoushtar Faculty of Medical Sciences, Alhadi Hospital, Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 9544
Email
navarbaf_n@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shoushtar Faculty 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
Shoushtar Faculty of Medical Sciences
Full name of responsible person
Azam Honarmandpour
Position
MSC of Midwifery, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran.
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shoushtar Faculty of Medical Sciences, Alhadi Hospital, Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 9544
Email
navarbaf_n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shoushtar Faculty of Medical Sciences
Full name of responsible person
Azam Honarmandpour
Position
MSC of Midwifery, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran.
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shoushtar Faculty of Medical Sciences, Alhadi Hospital, Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 9544
Email
navarbaf_n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shoushtar Faculty of Medical Sciences
Full name of responsible person
Azam Honarmandpour
Position
MSC of Midwifery, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran.
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shoushtar Faculty of Medical Sciences, Alhadi Hospital, Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 9544
Email
navarbaf_n@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The part of the data includes information about the main consequences or the like it is possible to share
When the data will become available and for how long
Start the access period 12 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
The data was used to check fungal infections in other parts of the body.
From where data/document is obtainable
By receiving the email of the responsible author at honarmandpour.a@gmail.com
What processes are involved for a request to access data/document
After requesting data by email, the data will be sent within 1-2 weeks