Protocol summary
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Study aim
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Determination of the effect of Nigella sativa oil on the outcome of missed abortion in women
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Design
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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.
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Settings and conduct
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Clinical trial; Women's Specialty Clinic; placebo-controlled
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Missed abortion
Exclusion criteria:Sensitivity to Nigella sativa
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Intervention groups
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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.
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Main outcome variables
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Evacuation of pregnancy products
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-02-10, 1397/11/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-04-21, 1398/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Nigella sativa oil on the outcome of missed abortion in women
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Public title
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The effect of Nigella sativa oil on the outcome of missed abortion in women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients with miss abortion
Exclusion criteria:
Sensitivity to Nigella sativa
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The researcher and the patient will have no information about the content of the capsules
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-04, 1397/08/13
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Ethics committee reference number
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IR.SKUMS.REC.1397.205
Health conditions studied
1
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Description of health condition studied
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missed abortion
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ICD-10 code
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O02.1
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ICD-10 code description
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Early fetal death with retention of dead fetus
Primary outcomes
1
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Description
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Evacuation of pregnancy products
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Timepoint
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three days after intervention
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Method of measurement
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Self-discharge
Intervention groups
1
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Description
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Intervention group: receive the herbal capsule containing 5gr Nigella sativa oil three times a day for three days.
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Category
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Treatment - Drugs
2
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Description
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control group: receive the placebo capsule three times a day for three days.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Deputy of Shahrekord University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Total data in article format
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When the data will become available and for how long
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1397
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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publication
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From where data/document is obtainable
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journals
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What processes are involved for a request to access data/document
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publication of article
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Comments
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