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Protocol summary
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Study aim
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Assessment of Black Seed effect on the biomarkers of patients with colorectal cancer.
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Design
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The study is done in Phase 2 clinical trials without a control group, with a single group, without blinding.
Patients with colorectal cancer who have performed colon surgery and they are in stage IIb and III colon cancer, participated in this study. 18 patients participate in this study.
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Settings and conduct
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A study is conducted at Qom Shahid Beheshti Hospital.
Patients with colorectal cancer who have undergone colon surgery are included in this study of 18 people in a sample group. Serum bio-markers will be evaluated at the baseline, 3 months following the treatment and the end of treatment due to investigation on probable effect of black seed capsule on decreasing bio-markers level.
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Participants/Inclusion and exclusion criteria
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entrance condition: Age between 20 and 70 years and achieving the first time chemical therapy after colorectal cancer surgery.
non entrance condition: Pregnant and lactating women.
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Intervention groups
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Black seed capsule
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Main outcome variables
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cancer antigen 19-9 (CA19-9); Carcino Embryonic Antigen (CEA)
General information
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Reason for update
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Due to the duration of treatment, multiplicity and side effects of chemotherapy drugs in patients with colorectal cancer included in the present study, many patients were excluded from the study and did not want to continue treatment. Therefore, due to the fact that in colorectal cancer, patients' tumor markers are examined and followed up, this study was performed as a clinical trial without blinding.
Also, due to the fact that the dose of black seed capsule per day is 1000 mg and this amount is allowed in all temperaments, so the use of temperament questionnaire was not done in patients.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180513039641N1
Registration date:
2018-08-29, 1397/06/07
Registration timing:
prospective
Last update:
2025-05-03, 1404/02/13
Update count:
2
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Registration date
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2018-08-29, 1397/06/07
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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2018-11-06, 1397/08/15
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Actual recruitment end date
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2020-03-15, 1398/12/25
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Trial completion date
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2020-11-02, 1399/08/12
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Scientific title
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Studying of Black Seed effect as a complementary chemotherapy treatment on biomarkers of patients with colorectal cancer
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Public title
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Studying of Black Seed effect on colorectal cancer
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 20 and 70 years
Patients who are aware of their colorectal cancer disease
Performing colorectal cancer Surgery
The existence of colorectal cancer-Stage IIb and III
The first time achieving chemical therapy after colorectal cancer surgery
Exclusion criteria:
Pregnant and lactating women and married women in childbearing age who do not use reliable contraceptive methods
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Age
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From 20 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
Actual sample size reached:
18
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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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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2018-05-01, 1397/02/11
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Ethics committee reference number
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IR.MUQ.REC.1397.015
Health conditions studied
1
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Description of health condition studied
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Colorectal cancer
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ICD-10 code
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C19
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ICD-10 code description
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Malignant neoplasm of rectosigmoid junction
2
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Description of health condition studied
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colon cancer
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ICD-10 code
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C18
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ICD-10 code description
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Malignant neoplasm of colon
3
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Description of health condition studied
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rectum cancer
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ICD-10 code
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C20
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ICD-10 code description
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Malignant neoplasm of rectum
Primary outcomes
1
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Description
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cancer antigen 19-9 (CA19-9)
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Timepoint
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Baseline, 3 months following the treatment and the end of treatment
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Method of measurement
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Blood test
2
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Description
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Carcino Embryonic Antigen (CEA)
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Timepoint
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Baseline, 3 months following the treatment and the end of treatment
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Method of measurement
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Blood test
Intervention groups
1
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Description
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Black seed capsule (containing fresh black seed powder) in the amount of 1000 mg three times a day (it is better to take black seed capsule 2 hours before or 2 hours after a meal).
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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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Ghoum 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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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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After receiving the results of the study, there are plans to publish the article in valid journals
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When the data will become available and for how long
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all the time
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To whom data/document is available
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Depending on the journal in which the study is published
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Under which criteria data/document could be used
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After receiving the results of the study, there are plans to publish the article in valid journals
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From where data/document is obtainable
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Depending on the journal in which the study is published
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What processes are involved for a request to access data/document
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Depending on the journal in which the study is published
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Comments
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