Efficacy of short term consumption of Chlorella Vulgaris as an additive on severity of depression, anxiety and stress in elderly patients compared to control group
To examine the effect of Chlorella Vulgaris on depression, anxiety and stress experienced by the elderly depressed patients
Design
A parallel, triple-blind randomized trial with a control group with 80 patients in phase 3 will be conducted, Randomization was carried out using a random function in excel
Settings and conduct
All participants 60 to 80 years of age with the diagnosis of major depression from Amin hospital, Esfahan will be included,
Double blinded, parallel study in which the experimental group will receive chlorella and the control group placebo, with their standard anti depressants.
Neither the participants nor the research team will be unaware of the contents of the capsules until the study ends.
Participants/Inclusion and exclusion criteria
Inclusion Criteria include:
Patients within the age range of 60-80 years;
Reading and writing ability;
Iranian nationality and ability to speak Persian;
Living with at least one family member;
Written consent from patient or family member;
Diagnosis of major depression based on DSM-V criteria certified by the research director (psychiatrist) that the patient has not been treated for depression at least in the past 4 weeks;
Exclusion Criteria include:
Any serious cognitive disorder;
Developing any unpredictable and undesired physical or mental problem during treatment;
Consuming Warfarin and chemotherapeutic agents such as; Azathioprine, Basiliximab, Cyclosporine, Daclizumab, Muromonab- CD3, Mycophenolate, Tacrolimus;
History of drug and alcohol abuse;
Uncontrolled diabetes or thyroid problem;
Intervention groups
Chlorella Vulgaris is administered as an additive along with their standard antidepressants prescribed while the control group will receive placebo along with their standard antidepressants prescribed
Main outcome variables
Severity of depression, anxiety and stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161010030255N5
Registration date:2022-06-18, 1401/03/28
Registration timing:prospective
Last update:2022-06-18, 1401/03/28
Update count:0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Victoria Omranifard
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
v_omranifard@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of short term consumption of Chlorella Vulgaris as an additive on severity of depression, anxiety and stress in elderly patients compared to control group
Public title
Efficacy of Chlorella Vulgaris in Elderly Depressed Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients within the age range of 60-80 years
Reading and writing ability
Iranian nationality and ability to speak Persian
Living with at least one family member
Written consent from patient or family member
Diagnosis of major depression based on DSM-V criteria certified by the research director (psychiatrist) that the patient has not been treated for depression at least in the past 4 weeks
Exclusion criteria:
Any serious cognitive disorder
Developing any unpredictable and undesired physical or mental problem during treatment
Consuming Warfarin and chemotherapeutic agents such as; Azathioprine, Basiliximab, Cyclosporine, Daclizumab, Muromonab- CD3, Mycophenolate, Tacrolimus
History of drug and alcohol abuse
Uncontrolled diabetes or thyroid problem
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who fulfill the required criteria will be selected and will be divided in blocks of two, then they will be sorted based on their national ID number. Based on random numbers the first and second place in each block will be decided.
For example for numbers 0-4 the first person will be assorted the letter A and the second person will be assorted the letter B and if numbers 5-9 appear the first person will be assorted the letter B and the second person will be assorted the letter A.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Capsules containing Chlorella Vulgaris and placebo are similar in color and are also packed in similar bottles labeled A and B, filled up by an anonymous person unknown to the participants and the research team.
اHowever, the participants will be aware of the study process and will enter the study after written consent, but they will not know whether they have received the capsule containing chlorella or placebo until the study ends.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
No 18, Sepehr complex, Sanayeh dead end, Makine khajoo street, Charbagh khajoo street
City
Isfahan
Province
Isfehan
Postal code
8143944191
Approval date
2022-04-26, 1401/02/06
Ethics committee reference number
IR.ARI.MUI.REC.1401.018
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
F33.9
ICD-10 code description
Major depressive disorder, recurrent, unspecified
Primary outcomes
1
Description
Severity of depression based on Geriatric Depression Scale (GDS)
Timepoint
Baseline data, after 6 and 12 weeks
Method of measurement
Persian version of Geriatric Depression Scale (GDS)
2
Description
Severity of depression based on Depression, Anxiety, Stress Scales (DASS)
Timepoint
Baseline data, after 6 and 12 weeks
Method of measurement
Persian version of Depression, Anxiety, Stress Scales (DASS)
3
Description
Severity of anxiety based on Depression, Anxiety, Stress Scales (DASS)
Timepoint
Baseline data, after 6 and 12 weeks
Method of measurement
Persian version of Depression, Anxiety, Stress Scales (DASS)
4
Description
Severity of stress based on Depression, Anxiety, Stress Scales (DASS)
Timepoint
Baseline data, after 6 and 12 weeks
Method of measurement
Persian version of Depression, Anxiety, Stress Scales (DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Elderly patients aged 60 to 80 years old diagnosed with depression will be treated with 300 - 1200 milligrams of chlorella vulgaris for 12 weeks with their standard anti depressants. As a powder chlorella vulgaris is distributed by Fardaye Sabz Iranian.
Category
Treatment - Drugs
2
Description
Control group: Elderly patients aged 60 to 80 years old diagnosed with depression will be receive 300 - 1200 milligrams of placebo for 12 weeks with their standard anti depressants
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital, Isfahan, iran
Full name of responsible person
Doctor Victoria Omaranifard
Street address
No 18, Sepehr complex, Sanayeh dead end, Makine khajoo street, charbaghkhajoo street
City
Isfahan
Province
Isfehan
Postal code
8143944191
Phone
+98 31 3223 4552
Email
sarinaght@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Siyavash, Deputy of research, Isfahan University of Medical Sciences
Street address
Isafahan university of medical sciences, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8789
Email
vcr-office@med.mui.ac.ir
Grant name
Research grant, Isfahan university of medical sciences
Grant code / Reference number
56615
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Victoria Omranifard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
EDC, Hezar jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8789
Email
v_omranifard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Victoria Omaranifard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan university of medical sciences, Hezar jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
v_omranifard@med.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Victoria Omranifard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan university of medical sciences, Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8789
Email
v_omranifard@med.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patients information is confidential
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
Information regarding the type of capsule consumed (Chlorella or placebo) and its effect will be revealed
When the data will become available and for how long
After study is complete
To whom data/document is available
Data will be revealed to all researchers
Under which criteria data/document could be used
For future research
From where data/document is obtainable
In order to access relative information one can visit research director Dr. Vicrotria Omranifard in geriatric department of Amin hospital located in Ebn sina road, Sonbolestan street, Esfahan, Iran or they can contact 00983131122020 or email the research director whose address is v_omranifard@med.mui.ac.ir
What processes are involved for a request to access data/document