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Evaluation of therapeutic effects of Nigella sativa extract on serum Brain-Derived Neurotrophic Factor (BDNF) and depression and anxiety score in patients with depression

Protocol summary

Study aim
Evaluation of therapeutic effects of Nigella sativa extract on serum Brain-Derived Neurotrophic Factor (BDNF) and depression and anxiety score in patients with depression referred to Artesh 505 hospital
Design
Clinical trial with control group with parallel groups, phase 2-3 on 50 patients
Settings and conduct
This study will be performed in 505 Artesh Hospital in Tehran and patients with depression will be treated with Nigella sativa capsules. Before and 6 weeks after treatment, the severity of depression as well as the level of serum BDNF in them will be measured and compared with the beginning of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 65 years, having Major Depression, referring to the 505 Artesh Hospital, treated only with sertraline, moderate to severe depression, having the written informed consent to participate in the study Exclusion criteria: failure to take medication regularly, drug intolerance, allergy to Nigella sativa, having systemic diseases, pregnancy or breastfeeding in women, tendency to leave during the study
Intervention groups
Intervention group: Patients in this group will be evaluated for depression severity and serum BDNF after entering the study. Patients will be then treated with capsules containing 1000 mg of Nigella sativa extract daily along with sertraline. After 6 weeks, the patients' depression level as well as the level of serum BDNF in them will be measured again. Control group: Patients in this group will be evaluated for depression severity and serum BDNF after entering the study. Patients will be then receiving placebo capsules, daily, containing starch along with sertraline. After 6 weeks, the patients' depression level as well as the level of serum BDNF in them will be measured again.
Main outcome variables
Severity of depression and the level of serum BDNF

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200217046523N17
Registration date: 2021-06-19, 1400/03/29
Registration timing: prospective

Last update: 2021-06-19, 1400/03/29
Update count: 0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-09, 1400/05/18
Expected recruitment end date
2021-09-09, 1400/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of Nigella sativa extract on serum Brain-Derived Neurotrophic Factor (BDNF) and depression and anxiety score in patients with depression
Public title
Nigella sativa extract and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years Having Major Depression Referring to the 505 Artesh Hospital Treated only with sertraline Moderate to severe depression Having the written informed consent to participate in the study
Exclusion criteria:
Failure to take medication regularly Drug intolerance Allergy to Nigella sativa Having systemic diseases Pregnancy or breastfeeding in women Tendency to leave during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Arteshof the of the Islamic Republic of Iran University of Medical Sciences
Street address
Artesh University of Medical Sciences, Etemadzadeh St., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.AJAUMS.REC.1399.220

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F33.0
ICD-10 code description
Major depressive disorder, recurrent, mild

Primary outcomes

1

Description
Severity of depression
Timepoint
At the beginning of the intervention and 6 weeks after treatment
Method of measurement
Using Depression, Anxiety and Stress Scale - 21 (DASS-21)

2

Description
Serum levels of Brain-Derived Neurotrophic Factor (BDNF)
Timepoint
At the beginning of the intervention and 6 weeks after treatment
Method of measurement
By enzyme-linked immunosorbent assay (ELISA) kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will be evaluated for depression severity through Depression, Anxiety and Stress Scale - 21 (DASS-21) questionnaire and serum BDNF through ELISA kits after entering the study. Patients will be then treated with capsules containing 1000 mg of Nigella sativa extract daily along with sertraline. After 6 weeks, the patients' depression level as well as the level of serum BDNF in them will be measured again.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will be evaluated for depression severity through Depression, Anxiety and Stress Scale - 21 (DASS-21) questionnaire and serum BDNF through ELISA kits after entering the study. Patients will be then receiving placebo capsules, daily, containing starch along with sertraline. After 6 weeks, the patients' depression level as well as the level of serum BDNF in them will be measured again.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
505 Arthesh hospital
Full name of responsible person
Vahid Donyavi
Street address
505 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
donyavi_vahid@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zeshk
Street address
Artesh University of Medical Sciences, Etemadzadeh St., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8833 7920
Email
Yousefi.Zeshk@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Vahid Donyavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
505 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
donyavi_vahid@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Vahid Donyavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
505 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
donyavi_vahid@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Vahid Donyavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
505 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
donyavi_vahid@yahoo.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
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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Artesh University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.
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