Protocol summary

Study aim
Determining the effect of Prongus Fluorase vaginal cream on candidal vulvovaginitis Comparison of Clotrimazole vaginal cream and Prongus Fluorase vaginal cream on candidal vulvovaginitis
Design
A clinical trial with a control group with a parallel group, three-blind, randomized on 112 patients, the rand function of Excel
Settings and conduct
, The vulvovaginal symptoms form in Women's clinic is completed, the mental symptoms of the vulvar and vagina such as itching, burning, and dyspareunia are determined by the client on a 10 cm visual analog scale, and the objective symptoms are recorded in the checklist according to the examiner's observations and the scoring system. Sobel placement is graded. Determining the severity and classification of candidal vulvaginitis is done through the total score of objective and subjective symptoms in the Sobel clinical scoring system. Total Sobel score greater than 4 is considered as a possible diagnosis of candidal vulvovaginitis, then using three swabs, one of the swabs is drawn on the slide and a drop of normal xylene is added and the prepared wet slide is examined, and the second swab is examined for fungal elements, potassium hydroxide is added.The researcher, the statistical analyst and the patient are blinded
Participants/Inclusion and exclusion criteria
Entry conditions: women of reproductive age, being married, having at least two symptoms of cheesy secretions and itching and a minimum Sobel score of 4 or a positive culture. No entry: lactating women, postmenopausal women, pregnant women, suffering from diabetes, history of allergy to jashir, history of allergy to clotrimazole vaginal cream.
Intervention groups
Intervention group: Jashir vaginal cream Control group: clotrimazole vaginal cream for one week, one 5 mg applicator
Main outcome variables
Direct observation of the vagina, vaginal pH, wet vaginal smear, culture of vaginal secretions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230521058245N1
Registration date: 2023-06-27, 1402/04/06
Registration timing: registered_while_recruiting

Last update: 2023-06-27, 1402/04/06
Update count: 0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Leila Ghayashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5145
Email address
leile.ghiasi.89400000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-25, 1402/04/04
Expected recruitment end date
2023-12-25, 1402/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and comparing the effect of Clotrimazole vaginal cream and Prongus Fluorase vaginal cream (Jashir plant) on candidal vulvovaginitis
Public title
Determining and comparing the effect of Clotrimazole vaginal cream and vaginal cream (Jashir plant) on candidal vulvovaginitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age (15 to 45 years) Being married Having at least two symptoms of cheesy secretions and itching Least a Sobel score of 4 Positive culture
Exclusion criteria:
Failure to participate in the study Lactating women Menopausal women Menstruation Pregnant women Having diabetes Women with immunodeficiency and immunosuppressive diseases Suffering from other vaginal infections and sexually transmitted infections Frequent and recurring candidal vulginitis History of allergy to Jashir
Age
From 15 years old to 45 years old
Gender
Female
Phase
0
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, the available sample method is used, then the research units are placed in two parallel groups by a simple random allocation method using a table of random numbers. 56 women are in clotrimazole vaginal cream users group and 56 women are in Jashir vaginal cream group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All people, including the researcher, the patient and the statistical analyst, are blinded to the drug allocation. The pharmacist will perform drug blinding. In order to blind Clotrimazole 1% cream made by a pharmaceutical company, under sterile conditions, it is emptied by the pharmacist into tubes similar to Jashir's vaginal cream tubes, then in order to differentiate the two drugs, they are coded as A and B codes by the pharmacist for each Vaginal cream is determined and after the study and statistical analysis, the code of each drug is stated by the pharmacist. The research team includes a gynecologist, a pharmacist and a midwife
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
No 402، Beach Park towards Imam Sajjad Hospital،Yasouj ،Kohgiluyeh and Boyerahmad province
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.YUMS.REC.1402.030

Health conditions studied

1

Description of health condition studied
Candidal vulvovaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina

Primary outcomes

1

Description
Although vaginitis is a candidate
Timepoint
Before the start of the intervention and 7 days after the end of the intervention
Method of measurement
The score obtained from Sobel clinical semi-quantitative system

2

Description
Dysparonychia due to candidal vulvovaginitis
Timepoint
Dysparonychia due to candidal vulvovaginitis
Method of measurement
Visual Analogue Scale

3

Description
Burning of the vulva and vagina
Timepoint
before the start of the intervention and 7 days after the end of the intervention
Method of measurement
Visual Analogue Scale

4

Description
White cheesy discharge
Timepoint
before the start of the intervention and 7 days after the end of the intervention
Method of measurement
According to the score obtained from the Sobel scoring system

5

Description
Edema vulva
Timepoint
before the start of the intervention and 7 days after the end of the intervention
Method of measurement
According to the score obtained from the Sobel scoring system

6

Description
Itching of the vulva and vagina
Timepoint
before the start of the intervention and 7 days after the end of the intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Improvement of candidal vaginitis
Timepoint
7 days after the end of the intervention
Method of measurement
Removal of symptoms and signs at the beginning and total Sobel severity score ≤ 2 and negative culture

Intervention groups

1

Description
Intervention group:Intervention group: Jashir vaginal cream for one week, one 5 mg applicator every night at bedtime vaginally
Category
Treatment - Drugs

2

Description
Control group: Clotrimazole vaginal cream for one week, one 5 mg applicator every night at bedtime vaginally
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's clinic of Yasouj city
Full name of responsible person
Leila Ghayashi
Street address
15 Golestan Street , Yasouj , Kohgiluyeh and Boyer Ahmad Province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875114
Phone
+98 74 9101 3813
Fax
+98 74 9101 3813
Email
leile.ghiasi.89400000@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Hekmatzadeh
Street address
No 402, Beach Park towards Imam Sajjad Hospital, Yasouj, Kohgiluyeh and Boyerahmad province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5145
Email
sf.hekmatzadeh@yahoo.com
Grant name
Yasouj Faculty of Medical Sciences
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

Person responsible for general inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Hekmatzadeh
Position
University professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 402, Beach Park towards Imam Sajjad Hospital, Yasouj, Kohgiluyeh and Boyerahmad province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5145
Email
sf.hekmatzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Hekmatzadeh
Position
University professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 402, Beach Park towards Imam Sajjad Hospital, Yasouj, Kohgiluyeh and Boyerahmad province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5145
Email
sf.hekmatzadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Leila Ghayashi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 402, Beach Park towards Imam Sajjad Hospital, Yasouj, Kohgiluyeh and Boyerahmad province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5145
Email
leile.ghiasi.89400000@gmail.com
Web page address

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
Individual data of participants by de-identifying individuals, research results
When the data will become available and for how long
Access period from 1402 to one year
To whom data/document is available
All researchers in academic and scientific institutions
Under which criteria data/document could be used
Study method and statistical analysis
From where data/document is obtainable
To the email address sf.hekmatzadeh@yahoo.com Yasuj University of Medical Sciences, Fatemeh Hekmatzadeh
What processes are involved for a request to access data/document
Request by email or attendance at Yasouj University of Medical Sciences
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