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The effect of Nigella sativa oil on the outcome of missed abortion in women

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History
# Registration date Revision Id
2 2019-02-10, 1397/11/21 79242
1 2019-02-10, 1397/11/21 78689
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  • Protocol summary

    Determination of the effect of Nigella sativa powder on the outcome of missed abortion in women
    Determination of the effect of Nigella sativa oil on the outcome of missed abortion in women
    تعیین تاثیر پودر سیاه دانه بر پیامد سقط فراموش شده در زنان
    تعیین تاثیر روغن سیاه دانه بر پیامد سقط فراموش شده در زنان
    In this study, 70 patients with Missed abortion with inclusion criteria are divided into two groups.control and intravention group, the control group receive only placebo , and the intervention group receive capsul containing 8 grams of nigella sativa three times a day for three days. after three days the therapeutic effects of the capsule will be examined.
    In this study, 70 patients with Missed abortion with inclusion criteria are divided into two groups.control and intravention group, the control group receive only placebo , and the intervention group receive capsul containing 5 grams of nigella sativa oilthree times a day for three days. after three days the therapeutic effects of the capsule will be examined.
    دراین مطالعه 70بیمارمبتلا به سقط فراموش شده دارای شرایط ورودبه دوگروه کنترل ومداخله تقسیم میشوند گروه کنترل تنها پلاسبودریافت می کنند و گروه مورد کپسول گیاهی محتوی 8 گرم پودرسیاه دانه به صورت سه بار در روز دریافت می کنند. بعد از سه روز اثرات درمانی کپسول بررسی خواهد شد.
    دراین مطالعه 70بیمارمبتلا به سقط فراموش شده دارای شرایط ورودبه دوگروه کنترل ومداخله تقسیم میشوند گروه کنترل تنها پلاسبودریافت می کنند و گروه مورد کپسول گیاهی محتوی 5 گرم روغن سیاه دانه به صورت سه بار در روز دریافت می کنند. بعد از سه روز اثرات درمانی کپسول بررسی خواهد شد.
    Intervention group: receive the herbal capsule containing 8gr Nigella sativa powder three times a day for three days. control group:receive the placebo capsul three times a day for three days.
    Intervention group: receive the herbal capsule containing5gr Nigella sativa oil three times a day for three days. control group:receive the placebo capsul three times a day for three days.
    گروه مداخله: کپسول گیاهی محتوی پودرسیاه دانه 8گرم به صورت سه بار در روز به مدت سه روز دریافت می کنند. گروه کنترل: کپسول پلاسبو به صورت سه بار در روز به مدت سه روز دریافت می کنند
    گروه مداخله: کپسول گیاهی محتوی روغن سیاه دانه 5گرم به صورت سه بار در روز به مدت سه روز دریافت می کنند. گروه کنترل: کپسول پلاسبو به صورت سه بار در روز به مدت سه روز دریافت می کنند

  • General information

    The effect of Nigella sativapowder on the outcome of missed abortion in women
    The effect of Nigella sativa oil on the outcome of missed abortion in women
    بررسی تاثیر پودر سیاه دانه بر پیامد سقط فراموش شده در زنان
    بررسی تاثیر روغن سیاه دانه بر پیامد سقط فراموش شده در زنان
    The effect of Nigella sativa powder on the outcome of missed abortion in women
    The effect of Nigella sativa oil on the outcome of missed abortion in women
    بررسی تاثیر پودر سیاه دانه بر پیامد سقط فراموش شده در زنان
    بررسی تاثیر روغن سیاه دانه بر پیامد سقط فراموش شده در زنان
    70 people who have been admitted to the study, are divided into two groups of 35 members by randomly balanced block assignment Blocked randomization is intended to ensure that exactly the equal number of participants in consecutive but equal intervals, enter into two therapeutic groups.The size of each block in this study is 35.
    To randomly assign patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. Even numbers will be allocated to treatment with a semi-solid product, from Nigella sativa and odd numbers to placebo
    70فرد دارای شرایط ورودبه مطالعه که قبلا توسط پزشک ویزیت شده اند،بااستفاده از روش بلوکی به دو گروه 35نفره تقسیم می شوند. تصادفي سازي بلوک شده به اين منظور است که مطمئن شويم دقيقاً تعداد مساوي شرکت کننده در فاصله زماني هاي متوالي ولي مساوي، وارد دوگروه درمانی مي شوند.سايز هر بلوک در این مطالعه 35 نفر می باشد.
    جهت تخصیص تصادفی بیماران به دو گروه درمان و پلاسبو توسط فرد سوم و با استفاده از برنامه کامپیوتر با روش تصادفی سازی ساده، به تعداد حجم، نمونه اعداد تصادفی ایجاد شده و به هر بیمار یک عدد اختصاص داده خواهد شد. اعداد زوج به درمان با فرآورده ی نیمه جامد موضعی از سیاهدانه و اعداد فرد به پلاسبو اختصاص داده خواهد شد

  • Intervention groups

    #1
    Intervention group: receive the herbal capsule containing 8gr Nigella sativa powder three times a day for three days.
    Intervention group: receive the herbal capsule containing 5gr Nigella sativa oil three times a day for three days.
    گروه مداخله: کپسول گیاهی محتوی 8 گرم پودر سیاه دانه به صورت سه بار در روز به مدت سه روز دریافت می کنند
    گروه مداخله: کپسول گیاهی محتوی 5 گرم روغن سیاه دانه به صورت سه بار در روز به مدت سه روز دریافت می کنند

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: معاونت پژوهشی دانشگاه علوم پزشکی شهرکرد
    Name of organization / entity - Persian: Research Deputy of Shahrekord University of Medical Sciences
    Full name of responsible person - English: Dr.Kamal Solati
    Full name of responsible person - Persian: دکترکمال صولتی
    Street address - English: Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
    Street address - Persian: شهرکرد،بلوارکاشانی، معاونت پژوهشی،دانشگاه علوم پزشکی شهرکرد
    City - English: Shahrekord
    City - Persian: شهرکرد
    Province: Chahar-Mahal-va-Bakhtiari
    Country: Iran (Islamic Republic of)
    Postal code: 8815713471
    Phone: +98 38 3334 2414
    Fax:
    Email: kamal@skums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Research Deputy of Shahrekord University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهرکرد
    Full name of responsible person - English: Dr.Kamal Solati
    Full name of responsible person - Persian: دکترکمال صولتی
    Street address - English: Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
    Street address - Persian: شهرکرد،بلوارکاشانی، معاونت پژوهشی،دانشگاه علوم پزشکی شهرکرد
    City - English: Shahrekord
    City - Persian: شهرکرد
    Province: Chahar-Mahal-va-Bakhtiari
    Country: Iran (Islamic Republic of)
    Postal code: 8815713471
    Phone: +98 38 3334 2414
    Fax:
    Email: kamal@skums.ac.ir
    Web page address:

Protocol summary

Study aim
Determination of the effect of Nigella sativa oil on the outcome of missed abortion in women
Design
In this study, 70 patients with Missed abortion with inclusion criteria are divided into two groups.control and intravention group, the control group receive only placebo , and the intervention group receive capsul containing 5 grams of nigella sativa oilthree times a day for three days. after three days the therapeutic effects of the capsule will be examined.
Settings and conduct
Clinical trial; Women's Specialty Clinic; placebo-controlled
Participants/Inclusion and exclusion criteria
Inclusion criteria: Missed abortion Exclusion criteria:Sensitivity to Nigella sativa
Intervention groups
Intervention group: receive the herbal capsule containing5gr Nigella sativa oil three times a day for three days. control group:receive the placebo capsul three times a day for three days.
Main outcome variables
Evacuation of pregnancy products

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120709010222N21
Registration date: 2019-02-10, 1397/11/21
Registration timing: registered_while_recruiting

Last update: 2019-02-14, 1397/11/25
Update count: 1
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nigella sativa oil on the outcome of missed abortion in women
Public title
The effect of Nigella sativa oil on the outcome of missed abortion in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with miss abortion
Exclusion criteria:
Sensitivity to Nigella sativa
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. Even numbers will be allocated to treatment with a semi-solid product, from Nigella sativa and odd numbers to placebo
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the patient will have no information about the content of the capsules
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.SKUMS.REC.1397.205

Health conditions studied

1

Description of health condition studied
missed abortion
ICD-10 code
O02.1
ICD-10 code description
Early fetal death with retention of dead fetus

Primary outcomes

1

Description
Evacuation of pregnancy products
Timepoint
three days after intervention
Method of measurement
Self-discharge

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receive the herbal capsule containing 5gr Nigella sativa oil three times a day for three days.
Category
Treatment - Drugs

2

Description
control group: receive the placebo capsule three times a day for three days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Belgheyse Mohammadi
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Kamal Solati
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.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
Total data in article format
When the data will become available and for how long
1397
To whom data/document is available
researchers
Under which criteria data/document could be used
publication
From where data/document is obtainable
journals
What processes are involved for a request to access data/document
publication of article
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