Protocol summary

Study aim
Determining the comparative effect of grape seed extract vaginal cream and clotrimazole on the treatment of candidal vaginitis
Design
A controlled, parallel-group, three-blind, randomized clinical trial on 70 patients with candidal vaginitis.
Settings and conduct
Women with vaginitis referred to women's clinics of hospitals affiliated to Ahvaz University of Medical Sciences. Then the women are examined and the symptoms are observed. Samples are taken from vaginal secretions and transferred to the laboratory, and after confirmation of candida vaginitis, clotrimazole cream or grape extract is given according to the group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate in the research, diagnosis of candidal vaginitis, not suffering from diabetes mellitus and diseases that weaken the immune system, not using broad-spectrum antibiotics in the last 2 weeks, not using vaginal douches in the last 48 hours, not using Vaginal drugs during the last week and also not using hormonal drugs during the last 3 months, not having iodine, not having candida infection more than 4 times a year. Non-entry criteria: vaginal bleeding, grape allergy, pregnancy and breastfeeding
Intervention groups
In both groups (grape extract cream and clotrimazole cream), patients will be asked to use one applicator (5 grams) of the cream intravaginally for one week.
Main outcome variables
Duration of treatment, burning, itching, secretions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181214041963N3
Registration date: 2023-03-08, 1401/12/17
Registration timing: prospective

Last update: 2023-03-08, 1401/12/17
Update count: 0
Registration date
2023-03-08, 1401/12/17
Registrant information
Name
Atefeh Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 0651
Email address
ebrahimiyan127@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vaginal cream of grape seed extract and clotrimazole on the treatment of candida vaginitis: a randomized clinical trial
Public title
The effect of grape seed extract vaginal cream on the treatment of candidal vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in research Diagnosis of candidal vaginitis (at least 3 points out of 18 symptom points), Marriage history Not being pregnant Lack of breastfeeding Not suffering from diabetes mellitus and diseases that weaken the immune system Not using broad-spectrum antibiotics in the last 2 weeks Not using vaginal douche in the last 48 hours Not using vaginal drugs during the last week Not using hormonal drugs during the last 3 months Not having audio Not having a candidal infection more than 4 times a year
Exclusion criteria:
Vaginal bleeding Addiction and alcohol consumption Allergy to grapes
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by the available method, in such a way that married and non-pregnant women who refer to the women's clinic of Ahvaz University of Medical Sciences due to candidal vaginitis and are eligible to enter the study are selected. The research units will be assigned to two intervention and control groups using the random block method (six blocks). In this way, the 6 possible states of the blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) will be listed first. And each block will be assigned a number from one to six. Then a number between one and six is randomly selected using the random number table, and then people are selected based on the block corresponding to the number. will be assigned to the intervention (A) and control (B) groups. This work will continue until the sample volume is completed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Grape extract cream and Clotrimazole cream will be specified by the pharmacist with a code, and the researcher, research units and statistical analysts do not know the content of the creams according to A and B codes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan St ، Jundi Shapur Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.AJUMS.REC.1401.556

Health conditions studied

1

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

Primary outcomes

1

Description
Improvement of candidiasis signs
Timepoint
6-8 next days
Method of measurement
Examination and laboratory test and check list

Secondary outcomes

1

Description
Improvement of disease recurrence
Timepoint
40 days after the intervention
Method of measurement
Examination and laboratory test and checklist

Intervention groups

1

Description
Intervention group: grape seed cream, which will be made in Jundishapur Faculty of Pharmacy of Medical Sciences. To prepare medicine, 35 empty metal tubes of 50 grams with 2% grape seed cream will be prepared and filled with 50 grams of tube from Tolo Gostar Bukhara company/along with an applicator/one applicator should be used inside the vagina every night for seven days.
Category
Treatment - Drugs

2

Description
Control group: Clotrimazole vaginal cream 2%, which will be manufactured in Jundishapur Faculty of Pharmacy, along with an applicator, one applicator should be used inside the vagina every night for seven days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's Clinic affiliated to Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Ebrahimian
Street address
Women's Clinic affiliated to Ahvaz University of Medical Sciences(Women's Clinic of Imam Hospital, Razi, Golestan)
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 040 5709
Email
‫ebrahimiyan127@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naghmeh Yazdi
Street address
Jundishapur Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 040 5709
Email
naghmehyazdi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Jundishapur Medical Sciences
Proportion provided by this source
70
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
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Ebrahimian
Position
P.hD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
ebrahimiyan127@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naghmeh Yazdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Jundishapur Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
naghmehyazdi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Ebrahimian
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
‫ebrahimiyan127@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The reviewed data can be shared without mentioning the names of people
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Policymakers, researchers in academic and scientific institutions
Under which criteria data/document could be used
If you have an official letter from the scientific center
From where data/document is obtainable
Request from the printed magazine and indexed sites, request via e-mail of the project manager
What processes are involved for a request to access data/document
6 months after completing the study of the application, the data will be sent to the project manager, if the conditions are met, up to two months.
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