History
# Registration date Revision Id
3 2023-12-12, 1402/09/21 338406
2 2020-11-10, 1399/08/20 158940
1 2018-08-29, 1397/06/07 57781
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  • Protocol summary

    The study is done in Phase 2 clinical trials with a control group, parallel groups، double-blind and randomized assessment. Patients with colorectal cancer who have performed colon surgery and they are in stage IIb and III colon cancer, participated in this study. 50 cases in each group of sample and control (in total 100 cases).
    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.
    مطالعه در فاز 2 کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور ، تصادفی انجام میگیرد. بیماران مبتلا به سرطان کولورکتال که عمل جراحی کولون را انجام داده اند و در مرحله IIb و III کنسر کولون قرار دارند، در این مطالعه شرکت می کنند. 50 بیمار در هر گروه نمونه و شاهد (مجموعا 100 بیمار)
    مطالعه در فاز 2 کارآزمایی بالینی بدون گروه کنترل، با گروه تنها، بدون کورسازی انجام میگیرد. بیماران مبتلا به سرطان کولورکتال که عمل جراحی کولون را انجام داده اند و در مرحله IIb و III کنسر کولون قرار دارند، در این مطالعه شرکت می کنند. 18 بیمار در این مطالعه شرکت میکنند.
    A study is conducted at Qom Shahid Beheshti Hospital. Patients with colorectal cancer who are undergone surgery will be divided in 2 groups of intervention and control, 100 individuals in each 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 in comparison with conventional therapy. Only the general responsive researcher is aware of the nature of the drugs and by assigning codes 1 and 2 to the drugs, the placebo and the main drug are identified.
    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.
    مطالعه در بیمارستان آموزشی درمانی شهید بهشتی قم انجام میگیرد. بیماران مبتلا به کانسر کولورکتال که عمل جراحی کولون را انجام داده ند به تعداد 100 نفر و در دو گروه نمونه و شاهد، در این مطالعه شرکت می نمایند. بیومارکرهای خونی ابتدای درمان، 3 ماه پس از شروع درمان و انتهای درمان با کپسول سیاه دانه در دو گروه اندازه گیری می شود تا اثر احتمالی این دارو در کاهش بیومارکرها در مقایسه با گروه کنترل که درمان رایج را دریافت می کنند بررسی شود. تنها محقق مسئول عمومی طرح از ماهیت داروها آگاه است و توسط اختصاص کد 1 و 2 به داروها، دارونما و داروی اصلی را شناسایی می کند.
    مطالعه در بیمارستان آموزشی درمانی شهید بهشتی قم انجام میگیرد. بیماران مبتلا به کانسر کولورکتال که عمل جراحی کولون را انجام داده اند به تعداد 18 نفر در یک گروه نمونه، در این مطالعه شرکت می نمایند. بیومارکرهای خونی ابتدای درمان، 3 ماه پس از شروع درمان و انتهای درمان با کپسول سیاه دانه در گروه نمونه اندازه گیری می شود تا اثر احتمالی این دارو در کاهش بیومارکرها بررسی شود.
    entrance condition: Age between 20 and 70 years and achieving the first time chemical therapy after colorectal cancer surgery. non entrance condition: Warm and dry temperate and Pregnant and lactating women.
    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.
    شرایط ورود: سن بین 20 تا 70 سال و دریافت اولین نوبت شیمی درمانی پس از عمل جراحی بر روی کولون. شرایط عدم ورود: مزاج گرم و خشک و خانم های باردار و شیرده.
    شرایط ورود: سن بین 20 تا 70 سال و دریافت اولین نوبت شیمی درمانی پس از عمل جراحی بر روی کولون. شرایط عدم ورود: خانم های باردار و شیرده.
    Black seed and placebo capsule, which both of them are in the same shape.
    Black seed capsule
    کپسول سیاه دانه و پلاسبو که هر دو به یک شکل هستند.
    کپسول سیاه دانه
  • General information

    Randomized
    N/A
    Double blinded
    Not blinded
    1
    1
    1
    1
    Used
    Not used
    Parallel
    Single
    empty
    18
    empty
    2018-11-06, 1397/08/15
    empty
    2020-03-15, 1398/12/25
    empty
    2020-11-02, 1399/08/12
    empty
    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.
    empty
    با توجه به طول مدت درمان، تعدد و عوارض داروهای شیمی درمانی در بیماران مبتلا به سرطان کولورکتال وارد شده به مطالعه حاضر، بسیاری از بیماران از مطالعه خارج شده و تمایل به ادامه درمان نداشتند. لذا با توجه به این موضوع که در سرطان کولورکتال، تومورمارکرهای بیماران بررسی و فالوآپ می شود، این مطالعه به صورت کارآزمایی بالینی بدون کورسازی انجام گرفته است. همچنین با توجه به اینکه دوز مصرفی کپسول سیاه دانه در روز 1000 میلی گرم می باشد و این میزان در همه مزاجها مجاز می باشد لذا استفاده از پرسشنامه مزاج در بیماران انجام نگرفت.
    Warm and dry temperate
    Pregnant and lactating women and married women in childbearing age who do not use reliable contraceptive methods
    Pregnant and lactating women and married women in childbearing age who do not use reliable contraceptive methods
    مزاج گرم و خشک
    خانم های باردار و شیرده و خانم های متاهلی که در سنین باروری هستند و از روش جلوگیری قابل اطمینانی استفاده نمی کنند
    خانم های باردار و شیرده و خانم های متاهلی که در سنین باروری هستند و از روش جلوگیری قابل اطمینانی استفاده نمی کنند
    Randomization is done based on block randomization method, and the block size in this study will be 4.
    تصادفی سازی بر اساس روش تصادفی سازی بلوکی انجام میشود و اندازه بلوک در این مطالعه 4 خواهد بود.
    The main drug and placebo are quite similar. Only the original researcher is aware of the nature of the drugs and by assigning codes 1 and 2 to the drugs, the placebo and the main drug are identified
    داروی اصلی و دارو نما کاملا به هم شبیه هستند. تنها محقق اصلی طرح از ماهیت داروها آگاه است و توسط اختصاص کد 1 و 2 به داروها، دارونما و داروی اصلی را شناسایی می کند
  • Ethics committees

    #1
    IR.MUQ.REC.1397.15
    IR.MUQ.REC.1397.015
  • Intervention groups

    #1
    500 mg of black seed capsule, at a dose of 1000 mg three times a day in combination with drugs of chemical therapy for patients in treatment group. The duration of treatment with black seed capsule is 6 month.
    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).
    تجویز کپسول سیاه دانه 500 میلی گرمی، به میزان 1000 میلی گرم سه بار در روز، همراه با داروهای شیمی درمانی برای بیماران گروه نمونه به مدت 6 ماه.
    کپسول سیاه دانه (حاوی پودر تازه سیاه دانه) به میزان 1000 میلی گرم و سه بار در روز (بهتر است کپسول سیاه دانه 2 ساعت قبل یا 2 ساعت بعد از غذا مصرف شود).
    #2
    Placebo
    empty
    Control group: placebo is capsule as the same shape and color as black seed capsule in combination with chemotherapy drugs , three times a day for 6 month.
    empty
    گروه کنترل: پلاسبو کپسولی است در شکل و رنگ مشابه کپسول سیاه دانه و همراه با داروهای شیمی درمانی برای بیماران گروه کنترل ، سه بار در روز به مدت 6 ماه.
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: مرکز آموزشی درمانی شهید بهشتی
    Name of recruitment center - Persian: Shaheed Beheshti Medical Education Center
    Full name of responsible person - English: طلیعه ملاباشی
    Full name of responsible person - Persian: talieh mollabashi
    Street address - English: بلوار شهید بهشتی
    Street address - Persian: Shaheed Beheshti blvd
    City - English: qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3719964797
    Phone: +98 25 3612 2000
    Fax: +98 25 3612 2855
    Email: hodaabolhasani@gmail.com
    Web page address:
    Name of recruitment center - English: Shaheed Beheshti Medical Education Center
    Name of recruitment center - Persian: مرکز آموزشی درمانی شهید بهشتی
    Full name of responsible person - English: Talieh Mollabashi
    Full name of responsible person - Persian: طلیعه ملاباشی
    Street address - English: Shaheed Beheshti Blvd
    Street address - Persian: بلوار شهید بهشتی
    City - English: Ghoum
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3719964797
    Phone: +98 25 3612 2000
    Fax: +98 25 3612 2855
    Email: dr.talieh918@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: حسین ثقفی
    Full name of responsible person - Persian: hosein saghafi
    Street address - English: No. 83, Alley 4, Alley 1/1, Safashahr St.
    Street address - Persian: خیابان صفاشهر، کوچه 1/1، کوچه 4، پلاک 83
    City - English: qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3716987366
    Phone: +98 25 3285 2720
    Fax: +98 25 3285 8464
    Email: hodaabolhasani@gmail.com
    Web page address: http://res.muq.ac.ir/index.aspx

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hosein Saghafi
    Full name of responsible person - Persian: حسین ثقفی
    Street address - English: No. 83, Alley 4, Alley 1/1, Safashahr St.
    Street address - Persian: خیابان صفاشهر، کوچه 1/1، کوچه 4، پلاک 83
    City - English: Ghoum
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3716987366
    Phone: +98 25 3285 2720
    Fax: +98 25 3285 8464
    Email: dr.hosseinsaghafi@gmail.com
    Web page address: http://res.muq.ac.ir/index.aspx
  • Sharing plan

    no
    na
    no
    undecided

Protocol summary

Study aim
Assessment of Black Seed effect on the biomarkers of patients with colorectal cancer.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Black seed capsule
Main outcome variables
cancer antigen 19-9 (CA19-9); Carcino Embryonic Antigen (CEA)

General information

Reason for update
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.
Acronym
IRCT registration information
IRCT registration number: IRCT20180513039641N1
Registration date: 2018-08-29, 1397/06/07
Registration timing: prospective

Last update: 2020-11-15, 1399/08/25
Update count: 2
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Hoda Abolhasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3320 9071
Email address
habolhasani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
2018-11-06, 1397/08/15
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-11-02, 1399/08/12
Scientific title
Studying of Black Seed effect as a complementary chemotherapy treatment on biomarkers of patients with colorectal cancer
Public title
Studying of Black Seed effect on colorectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Qom University of Medical Sciences
Street address
No. 83, Alley No. 4, Alley 1/1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2018-05-01, 1397/02/11
Ethics committee reference number
IR.MUQ.REC.1397.015

Health conditions studied

1

Description of health condition studied
Colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction

2

Description of health condition studied
colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon

3

Description of health condition studied
rectum cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum

Primary outcomes

1

Description
cancer antigen 19-9 (CA19-9)
Timepoint
Baseline, 3 months following the treatment and the end of treatment
Method of measurement
Blood test

2

Description
Carcino Embryonic Antigen (CEA)
Timepoint
Baseline, 3 months following the treatment and the end of treatment
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
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).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Beheshti Medical Education Center
Full name of responsible person
Talieh Mollabashi
Street address
Shaheed Beheshti Blvd
City
Ghoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
+98 25 3612 2855
Email
dr.talieh918@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hosein Saghafi
Street address
No. 83, Alley 4, Alley 1/1, Safashahr St.
City
Ghoum
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Fax
+98 25 3285 8464
Email
dr.hosseinsaghafi@gmail.com
Web page address
http://res.muq.ac.ir/index.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Hoda Abolhasani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medicinal Chemistry
Street address
Pharmacology group, medicin faculty, Ghoum pardis university of medical sciences
City
Ghoum
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3320 9071
Email
hodaabolhasani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Davoud Ouladdameshghi
Position
Assistance Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Shaheed Beheshti Blvd
City
Ghoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dodameshghi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hoda Abolhasani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medicinal Chemistry
Street address
Pharmacology group, medicin faculty, Ghoum pardis university of medical sciences
City
Ghoum
Province
Ghoum
Postal code
3716985598
Phone
+98 25 3320 9071
Email
hodaabolhasani@gmail.com

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
Not applicable
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
After receiving the results of the study, there are plans to publish the article in valid journals
When the data will become available and for how long
all the time
To whom data/document is available
Depending on the journal in which the study is published
Under which criteria data/document could be used
After receiving the results of the study, there are plans to publish the article in valid journals
From where data/document is obtainable
Depending on the journal in which the study is published
What processes are involved for a request to access data/document
Depending on the journal in which the study is published
Comments
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