Protocol summary

Study aim
Using the most appropriate drug combination to improve genital skin inflammation in patients with candidal vaginitis by comparing the effect of harpagophytum procumbens extract and topical hydrocortisone in improving genital skin inflammation in these patients
Design
Clinical trial with control group, with parallel groups, triple blinded, randomized, phase 3 on 60 patients
Settings and conduct
Eligible people referring to Isfahan women's clinics in the years 1400 to 1401 are divided into two groups by using random assignment software. Patients' self-report sheet of their condition based on when the patient recovers from common complaints will be filled after taking medication at home and we will recommend them to refer again after treatment. In this study, the blind groups are patient, therapist, researcher, outcome evaluator, and data analyzer. Blinding is in the form of envelopes containing random codes for patients.
Participants/Inclusion and exclusion criteria
Being15 to 50 years old, Being married, Examining the symptoms of acute candidate vaginitis, Not taking broad-spectrum antibiotics in the last two weeks, Not using oral and vaginal medications related to the treatment of genital infections in the last two weeks, Lack of history of allergies to the ingredients in the creams, No trichomoniasis vaginitis
Intervention groups
Intervention is in the form of using a drug containing clotrimazole, idoquinol, aloe vera gel and Harpagophytum procumbens extract in one group and clotrimazole, idoquinol, aloe vera gel and hydrocortisone in the other group twice a day topically on the external genitalia and to It takes 7 days.
Main outcome variables
Measurement of burning, itching, inflammation and redness of the genitalia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210508051222N1
Registration date: 2021-06-30, 1400/04/09
Registration timing: prospective

Last update: 2021-06-30, 1400/04/09
Update count: 0
Registration date
2021-06-30, 1400/04/09
Registrant information
Name
reyhaneh daryabeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 4028
Email address
tahereh.khalili@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Harpagophytum procumbens and topical Hydrocortisone in improving genital skin inflammation in patients with candidiasis
Public title
Comparison of the effect of Harpagophytum procumbens and topical Hydrocortisone in improving genital skin inflammation in patients with candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an age range of fifteen to fifty years Being married Signs and symptoms of candidate vaginitis in the interview
Exclusion criteria:
Use of broad-spectrum antibiotics in the last two weeks Use of oral and vaginal medications related to the treatment of genital infections during the last two weeks Any allergies to the drug compounds used in the research Trichomonas vaginitis
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with a simple random method and creating random values between zero and one in spss software. Values equal or less than 0.5 are assigned to group A and values greater than 0.5 are assigned to group B. Then, a person who was not a member of research team encodes 60 envelopes (based on the codes obtained in the randomization method) and determines the list of codes. New treatment or standard (conventional) treatment will be written in the envelope. One envelope will be given to each eligible patient according to their order of entry in the clinic to give to the specialist. The clinician will prescribe and make the necessary recommendations for each patient based on the grouping done. The researchers are blinded to patients group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The secretary introduces the patients to the clinician based on the random allocated groups. Clinician provides treatment for each group according to their grouping. The researcher in collaboration with the clinician monitors patient’s medication use. After collecting the data of the questionnaire that was completed by the patients, the data is given to the statistical specialist for analysis. Statistical specialist is blinded to patients group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
No. 119, Alborz Alley, 7th Alley, Hosseinzadeh Alley, Jahad St.
City
isfahan
Province
Isfehan
Postal code
8183886761
Approval date
2021-05-04, 1400/02/14
Ethics committee reference number
IR.MUI.MED.REC.1400.086

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
the amount of burning of external genitalia
Timepoint
Before the start of the study and 7 days after taking the drug
Method of measurement
5-points checklist

2

Description
the amount of itching of external genitalia
Timepoint
Before the start of the study and 7 days after taking the drug
Method of measurement
5-points checklist

3

Description
Amount of redness and swelling of the external genitalia
Timepoint
Before the start of the study and 7 days after taking the drug
Method of measurement
5-points checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The weight of each ointment used in this group is 20 to 30 grams, which includes cold cream base made by Naghsh Jahan Company, Dr. Shahtalebi, and contains 20% of aloe vera gel extracted from the leaves, clotrimazole 2%, idoquinol 1% and 480 mg extract of Harpagophytum procumbens. Which is for external use and 2 times a day for a week.
Category
Treatment - Drugs

2

Description
Control group: Intervention group: The weight of each ointment used in this group is 20 to 30 grams, which includes cold cream base made by Naghsh Jahan Company, Dr. Shahtalebi, and contains 20% of aloe vera gel extracted from the leaves, clotrimazole 2%, idoquinol 1% and Hydrocortisone sodium succinate 1% . Which is for external use and 2 times a day for a week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Minoo Movahedi, Maryam Haji Hashemi, Tahereh Khalili, Reyhaneh Daryabeigi
Street address
No. 119, Alborz Alley, 7th Alley, Hosseinzadeh Alley, Jahad St.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Email
reihaneh_da_75@yahoo.com

2

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Minoo Movahedi, Maryam Haji Hashemi, Tahereh Khalili, Reyhaneh Daryabeigi
Street address
No. 119, Alborz Alley, 7th Alley, Hosseinzadeh Alley, Jahad St.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Email
reihaneh_da_75@yahoo.com

3

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Minoo Movahedi, Maryam Haji Hashemi, Tahereh Khalili, Reyhaneh Daryabeigi
Street address
No. 119, Alborz Alley, 7th Alley, Hosseinzadeh Alley, Jahad St.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Email
reihaneh_da_75@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh Jooi Javanmard
Street address
No. 119, Alborz Alley, 7th Alley, Hosseinzadeh Alley, Jihad St.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Email
reihaneh_da_75@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reyhaneh Daryabeigi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No119, Alborz alley, Hossein zade alley, N7 Alley, jahad Aven.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Fax
Email
tahereh.khalili@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reyhaneh Daryabeigi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No119, Alborz alley, Hossein zade alley, N7 Alley, jahad Aven.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Fax
Email
tahereh.khalili@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reyhaneh Daryabeigi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No119, Alborz alley, Hossein zade alley, N7 Alley, jahad Aven.
City
Isfahan
Province
Isfehan
Postal code
8183886761
Phone
+98 31 3236 4028
Fax
Email
tahereh.khalili@med.mui.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
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