Protocol summary

Study aim
Determining effects of vaginal cream of bunium persicum (black zera) on candida albicans vaginitis
Design
Triple blinded clinical trial, parallel groups, Phase 2 on 100 women Random allocation with software Minitab11
Settings and conduct
The researcher goes to the clinic of Kashani Hospital in Jiroft and, by explaining the objectives, receives written written consent. Sampling is performed by two sterile cotton swabs from the lateral wall and vaginal discharge. On the second slide, add a 10% potash drop, and if the mycelium or hyphae blastopur was under a microscope, the sample is positive. The second swab for smear and staining with Gimsa to more accurately diagnose mycelium is Hif Yablastopur, and if the second lam is positive, 10 landa removes vaginal discharge and is cultured for 48 hours on a chrom agar medium at 27 C sel. In the first stage, the samples will be randomly divided into two groups: clotrimazole ointment and black cumin. They use clotrimazole ointment or Kermani black cumin for 7 nights. The instructions for use are called cream and hygienic recommendations. Drugs are followed up, they are taken out of the study with drug side effects. On day 8, the sample will be taken again and culture will be performed
Participants/Inclusion and exclusion criteria
Married women 49-15 years of age,no pregnancy or lactation,no antifungal use,no antibiotics in recent weeks,no hypersensitivity to black bean colostrum,no chronic disease Output criteria: overuse of forgetfulness, drug allergy or intolerance,pregnancy,vaginal bleeding, and unwillingness to cooperate
Intervention groups
Black cumin and clotrimazole ointment
Main outcome variables
Improving and accelerating the treatment of candid vaginitis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200415047087N1
Registration date: 2020-06-09, 1399/03/20
Registration timing: registered_while_recruiting

Last update: 2020-06-09, 1399/03/20
Update count: 0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
sareh mehni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 5306
Email address
sa.mehni@jmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the therapeutic effects of vaginal cream of bunium persicum (black zera) on candida albicans vaginitis
Public title
the therapeutic effects of vaginal cream of bunium persicum (black zera) on candida albicans vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women in the age range of 15-49 years No pregnancy or breastfeeding Do not use oral or topical antifungals to treat vaginal infections in the last two weeks Lack of sensitivity to clotrimazole and black cumin Lack of use of antibiotics and immunosuppressive drugs in the last two weeks Not suffering from chronic diseases such as diabetes
Exclusion criteria:
More than once forgetting to use medication Sensitivity or intolerance to the drug used get pregnant Abnormal vaginal bleeding Lack of willingness to cooperate with participants
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be such that in the mini-tab software of version 11, the numbers 1-100 are entered, then 50 pieces will be selected randomly by this software. People who have entered the study number with the same 50 selected numbers will be given drug A and the remaining 50 people will be given drug B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, participants will be blinded by the shape, size and smell of ointments. Also, to blind the researcher and analyze the data, the drugs will be divided into two groups A and B without their knowledge of each group, and thus blinding these people will be done.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jiroft University of Medical Sciences
Street address
Pasdaran Blvd
City
Jiroft
Province
Kerman
Postal code
7861763730
Approval date
2017-01-20, 1395/11/01
Ethics committee reference number
IR.JMU.REC.1395.14

Health conditions studied

1

Description of health condition studied
Vulvo vaginal Candidiasis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere

Primary outcomes

1

Description
Percentage of women with positive vaginal discharge for candid vaginitis
Timepoint
1 and 8 day
Method of measurement
Chromium agar culture medium

Secondary outcomes

1

Description
Cultivation of vaginal secretions for candid vaginitis
Timepoint
8 day
Method of measurement
Chromium agar culture medium

Intervention groups

1

Description
Intervention group: Women treated with black cumin ointment, 1% black cumin ointment, one application every night for 7 nights, It has been prepared in the Faculty of Pharmacy of Kerman University of Medical Sciences
Category
Treatment - Drugs

2

Description
Control group: Women treated with clotrimazole ointment, 1% clotrimazole ointment made by Pars Daru Company, one applicator for 7 nights every night
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital in Jiroft
Full name of responsible person
Sareh Mehni
Street address
Nurse Street
City
Jiroft
Province
Kerman
Postal code
7861733616
Phone
+98 34 4326 2401
Email
sareh.mehni@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Fatemeh Seydi
Street address
Pasdaran Boulevard
City
Jiroft
Province
Kerman
Postal code
7861763730
Phone
+98 34 4331 7302
Email
fa.seydi@jmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Jiroft 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
Jeeroft University of Medical Sciences
Full name of responsible person
Sareh Mehni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Pasdaran Street
City
Jiroft
Province
Kerman
Postal code
7861733616
Phone
+98 34 4331 5304
Email
sa.mehni@jmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Sareh Mehni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Pasdaran Street
City
Jiroft
Province
Kerman
Postal code
7861733616
Phone
+98 34 4331 5304
Email
sa.mehni@jmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Sareh Mehni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Pasdaran Street
City
Jiroft
Province
Kerman
Postal code
7861733616
Phone
+98 34 4331 5304
Email
sa.mehni@jmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
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
Title and more details about the data/document
In this study, the study protocol, statistical analysis map and conscious consent form will be published.
When the data will become available and for how long
1400
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Give citation if used
From where data/document is obtainable
sa.mehni@jmu.ac.ir
What processes are involved for a request to access data/document
The applicant must send an e-mail to the e-mail address listed in the previous section. Then their e-mail will be checked and finally, at the first opportunity, their request will be answered within a maximum of one week and the desired document will be sent.
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