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The evaluation of Nigella sativa and honey on platelet in patients with thrombocytopenia following chemotherapy or radiotherapy

Protocol summary

Study aim
The evaluation of Nigella sativa and honey on platelet in patients with thrombocytopenia following chemotherapy or radiotherapy
Design
Non_random Clinical trial, with control group, design of 80 patients, enrolled December 2020 and June 2021, and followed for two weeks
Settings and conduct
Zanjan's valiasr hospital's patients with thrombocytopenia receive a combination of black seed and honey twice a day for two weeks
Participants/Inclusion and exclusion criteria
people who develop thrombocytopenia due to chemotherapy or radiotherapy
Intervention groups
Comparison of the control group with the experimental group that received black seed and honey
Main outcome variables
Increased patient platelets

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210317050733N1
Registration date: 2021-04-04, 1400/01/15
Registration timing: registered_while_recruiting

Last update: 2021-04-04, 1400/01/15
Update count: 0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Sare Hosseini shayan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5525 2567
Email address
sare.shayan1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of Nigella sativa and honey on platelet in patients with thrombocytopenia following chemotherapy or radiotherapy
Public title
Effect of Nigella sativa and honey on platelets
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people who develop thrombocytopenia due to chemotherapy or radiotherapy
Exclusion criteria:
People who are younger than 18 year's old Diabetic person Pregnant woman
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of zanjan University of medical science
Street address
No 1,Kordabadi St, Asadi St, Estabraghi St, Sharak-e-Golshar, Chahardangeh, Tehran, Iran
City
Zanjan
Province
Zanjan
Postal code
3319744581
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.ZUMS.REC.1399.262

Health conditions studied

1

Description of health condition studied
Thrombocytopenia due to chemotherapy or radiotherapy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Platelet count
Timepoint
Measurement of platelet count at the beginning of the study and 7 and 14 days after consuming black seed and honey
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1.5 grams of black seed and 5 grams of honey are mixed in a glass of water and given to the patients twice a day for one to two weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital, Zanjan
Full name of responsible person
Dr zhale karimimoghadam
Street address
No 1,Kordabadi St, Asadi St, Estabraghi St, Sharak-e-Golshar, Chahardangeh, Tehran, Iran
City
Zanjan
Province
Zanjan
Postal code
3319744581
Phone
+98 21 5525 2566
Email
sare.shayan1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr saeed rezayi
Street address
No 1,Kordabadi Alley, Asadi St, Estabraghi St, Sharak-e-Golshar, Chahardangeh, Tehran, Iran
City
Zanjan
Province
Zanjan
Postal code
3319744581
Phone
+98 21 5525 2567
Email
sare.shayan1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Sare hosseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 1,Kordabadi Alley, Asadi St, Estabraghi St, Sharak-e-Golshar, Chahardangeh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319744581
Phone
+98 21 5525 2567
Email
sare.shayan1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sare hosseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 1,Kordabadi Alley, Asadi St, Estabraghi St, Sharak-e-Golshar, Chahardangeh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319744581
Phone
+98 21 5525 2567
Email
sare.shayan1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sare hosseini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 1,Kordabadi Alley, Asadi St, Estabraghi St, Sharak-e-Golshar, Chahardangeh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319744581
Phone
+98 21 5525 2567
Email
sare.shayan1@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
Undecided - It is not yet known if there will be 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
Information about the main outcome can be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Everyone will have access
Under which criteria data/document could be used
Research work only
From where data/document is obtainable
Library of Zanjan University of Medical Sciences
What processes are involved for a request to access data/document
Refer to Dr zhale karimimoghadam Refer to the library of Zanjan University of Medical Sciences
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