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Protocol summary
The two groups of 32 people, including the intervention and control groups, will use 250 mg of Lemon Balm capsules in the intervention group and 300 mg of starch capsules in the control group.
The two groups of 32 people, including the intervention and control groups, will use 320 mg of Lemon Balm capsules in the intervention group and 320 mg of starch capsules in the control group.
The two groups of 32 people, including the intervention and control groups, will use 250320 mg of Lemon Balm capsules in the intervention group and 300320 mg of starch capsules in the control group.
دو گروه 32 نفره شامل گروه مداخله و شاهد که در گروه مداخله از کپسول بادرنجبویه ۲۵۰ میلی گرم و در گروه کنترل نیز از کپسول های خوراکی حاوی نشاسته به میزان ۳۰۰ میلی گرم استفاده خواهد شد.
دو گروه 32 نفره شامل گروه مداخله و شاهد که در گروه مداخله از کپسول بادرنجبویه 320 میلی گرم و در گروه کنترل نیز از کپسول های خوراکی حاوی نشاسته به میزان 320 میلی گرم استفاده خواهد شد.
دو گروه 32 نفره شامل گروه مداخله و شاهد که در گروه مداخله از کپسول بادرنجبویه ۲۵۰320 میلی گرم و در گروه کنترل نیز از کپسول های خوراکی حاوی نشاسته به میزان ۳۰۰320 میلی گرم استفاده خواهد شد.
Intervention groups
#1
Intervention Group: 32 Depressed patients treated with ECT, receiving 250 mg of Lemon Balm Capsule made from the leaves of this plant made by Gol Daroo Company twice a week every 12 hoursthree times a week ECT and then one month evaluation with a questionnaire
Intervention group: 32 depressed patients treated with ECT, receiving 320 mg lemon balm capsules (made by the researcher) twice a week every 12 hours and three times a week after ECT and after a Evaluation month with questionnaire
Intervention Groupgroup: 32 Depresseddepressed patients treated with ECT, receiving 250320 mg of Lemon Balm Capsule made from the leaves of this plant lemon balm capsules (made by Gol Daroo Companythe researcher) twice a week every 12 hoursthreehours and three times a week after ECT and then oneafter a Evaluation month evaluation with a questionnaire
گروه مداخله: 32 نفر از بیماران افسرده تحت درمان با ECT ، دریافت کننده کپسول بادرنجبویه ۲۵۰ میلی گرم که از برگ این گیاه ساخته ی شرکت گل دارو هفته ای دو بار هر 12 ساعت و سه بار در هفته ECT و بعد از یک ماه ارزیابی با پرسشنامه
گروه مداخله: 32 نفر از بیماران افسرده تحت درمان با ECT ، دریافت کننده کپسول دست ساز بادرنجبویه 320 میلی گرم از برگ این گیاه (که توسط پژوهشگر ساخته شده است) هفته ای دو بار هر 12 ساعت و سه بار در هفته ECT و بعد از یک ماه ارزیابی با پرسشنامه
گروه مداخله: 32 نفر از بیماران افسرده تحت درمان با ECT ، دریافت کننده کپسول دست ساز بادرنجبویه ۲۵۰320 میلی گرم که از برگ این گیاه (که توسط پژوهشگر ساخته ی شرکت گل داروشده است) هفته ای دو بار هر 12 ساعت و سه بار در هفته ECT و بعد از یک ماه ارزیابی با پرسشنامه
#2
Control Group: 32 Depressed patients treated with ECT receiving oral capsules containing 300 mg twice a week every 12 hours and three times a week ECT and then one month evaluation with a questionnaire
Control Group: 32 Depressed patients treated with ECT receiving oral capsules containing 320 mg twice a week every 12 hours and three times a week ECT and then one month evaluation with a questionnaire
Control Group: 32 Depressed patients treated with ECT receiving oral capsules containing 300320 mg twice a week every 12 hours and three times a week ECT and then one month evaluation with a questionnaire
گروه کنترل: 32 نفر از بیماران افسرده تحت درمان با ECT دریافت کننده کپسول های خوراکی حاوی نشاسته به میزان ۳۰۰ میلی گرم دو بار در هفته هر 12 ساعت و سه بار در هفته ECT و بعد یک ماه ارزشیابی با پرسشنامه
گروه کنترل: 32 نفر از بیماران افسرده تحت درمان با ECT دریافت کننده کپسول های خوراکی حاوی نشاسته به میزان 320میلی گرم دو بار در هفته هر 12 ساعت و سه بار در هفته ECT و بعد یک ماه ارزشیابی با پرسشنامه
گروه کنترل: 32 نفر از بیماران افسرده تحت درمان با ECT دریافت کننده کپسول های خوراکی حاوی نشاسته به میزان ۳۰۰ میلی320میلی گرم دو بار در هفته هر 12 ساعت و سه بار در هفته ECT و بعد یک ماه ارزشیابی با پرسشنامه
Recruitment centers
#1
Name of recruitment center - English: Hajar Hospital in Shahrekord
Name of recruitment center - Persian: بیمارستان هاجر شهرکرد
Full name of responsible person - English: MASOUD NICFARJAM
Full name of responsible person - Persian: مسعود نیک فرجام
Street address - English: West Mirabad, 12 Jihad St., Alvand St.
Street address - Persian: میراباد غربی خیابان جهاد خیابان الوند 12
City - English: SHAHREKORD
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8817917546
Phone: +98 38 3338 8836
Fax:
Email: FATEMEH.KAVIANI950@GMAIL.COM
Web page address:
Name of recruitment center - English: Hajar Hospital in Shahrekord
Name of recruitment center - Persian: بیمارستان هاجر شهرکرد
Full name of responsible person - English: Majid Taheri
Full name of responsible person - Persian: مجید طاهری
Street address - English: Hajar Hospital , Parastar St.
Street address - Persian: خیابان پرستار ، بیمارستان هاجر
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8817917546
Phone: +98 38 3338 8836
Fax:
Email: Info@Skums.ac.ir
Web page address:
Name of recruitment center - English: Hajar Hospital in Shahrekord Name of recruitment center - Persian: بیمارستان هاجر شهرکرد Full name of responsible person - English: MASOUD NICFARJAMMajid Taheri Full name of responsible person - Persian: مسعود نیک فرجاممجید طاهری Street address - English: West MirabadHajar Hospital , 12 Jihad St., AlvandParastar St. Street address - Persian: میراباد غربی خیابان جهاد خیابان الوند 12پرستار ، بیمارستان هاجر City - English: SHAHREKORDShahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8817917546 Phone: +98 38 3338 8836 Fax: Email: FATEMEH.KAVIANI950Info@GMAIL.COMSkums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: MASOUD NICFARJAM
Full name of responsible person - Persian: مسعود نیک فرجام
Street address - English: RAHMATIE UNIVERSITR OF MEDICAL SIENCE OF SHAHREKORD
Street address - Persian: رحمتیه دانشگاه علوم پزشکی شهرکرد
City - English: SHAHREKORD
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3333 0061
Fax:
Email: INFO@SKUMS.AC.IR
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Esfandiar Heydarian
Full name of responsible person - Persian: دکتر اسفندیار حیدریان
Street address - English: Shahrekord University of Medical Sciences , Kashani St .
Street address - Persian: خیابان کاشانی ، دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3333 0061
Fax:
Email: Pajoohesh@Skums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: MASOUD NICFARJAMDr. Esfandiar Heydarian Full name of responsible person - Persian: مسعود نیک فرجامدکتر اسفندیار حیدریان Street address - English: RAHMATIE UNIVERSITR OF MEDICAL SIENCE OF SHAHREKORDShahrekord University of Medical Sciences , Kashani St . Street address - Persian: رحمتیهخیابان کاشانی ، دانشگاه علوم پزشکی شهرکرد City - English: SHAHREKORDShahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8815713471 Phone: +98 38 3333 0061 Fax: Email: INFOPajoohesh@SKUMS.AC.IRSkums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of Lemon Balm Capsule on Cognitive Disorders in Depressed Patients treated with ECT
Design
Sampling will first be done in an accessible way that all hospitalized patients who met the study conditions will be included in the study. Random allocation of people to two groups will be done by randomization of permutation blocks and using software, random allocation
Settings and conduct
Necessary referral letters will be provided to the psychiatric ward of Hajar Hospital and after sampling through random allocation, they will be placed in intervention and control groups.The Study is a Blind One-Way study in which data analysts do not know about the drug used
Participants/Inclusion and exclusion criteria
Participants in this study were 64 patients treated with ECT
Inclusion Criteria: The age range of patients is 18-65 years; their Major Depressive Disorder has been confirmed by a psychiatrists; the patient has no history of allergy to the mint family; lack of physical illness leading to Cognitive Impairment such as Head Trauma, Dementia, Retardation-Mental Retardation and Epilepsy; patients receiving SSRIs (according to a psychiatrist).
Exclusion Criteria: Patients who have other Mental Disorders in addition to Depression; reluctance to continue cooperation before the end of the project; occurrence of stressful events affecting the Patient's mood during the implementation of the plan; use of other Antidepressants Drugs (except SSRIs)
Intervention groups
The two groups of 32 people, including the intervention and control groups, will use 320 mg of Lemon Balm capsules in the intervention group and 320 mg of starch capsules in the control group.
Main outcome variables
ImprovesPost-ECT Amnesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180613040083N1
Registration date:2022-06-10, 1401/03/20
Registration timing:retrospective
Last update:2022-08-30, 1401/06/08
Update count:2
Registration date
2022-06-10, 1401/03/20
Registrant information
Name
Fatemeh Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 8836
Email address
fatemeh.kaviani950@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Melissa Officinalis L ( Lemon Balm) Capsule on Cognitive Impairment in Depressed Patients Treated With ECT
Public title
Evaluation of the Effect of Melissa Officinalis L ( Lemon Balm) Capsule on Cognitive Impairment in Depressed Patients Treated With ECT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of patients is 18-65 years.
Their Major Depressive Disorder has been confirmed by a psychiatrist
The patient has no history of allergy to The mint family.
Lack of physical illness leading to Cognitive Impairment such as Head Trauma, Dementia, Retardation - Mental Retardation And EpilepsyPatients
Receiving SSRIs (according to a psychiatrist).
Exclusion criteria:
Patients who have other Mental Misorders in addition to Depression..
Reluctance to continue cooperation before The end of the project
Occurrence of stressful events affecting The patient's mood during the implementation of The plan
Use of other Antidepressants Drugs(except SSRIs)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign individuals to two groups, using the randomization Replacement blocks method were used. By using the software, a random block of fifteen blocks with a volume of six was designed and a randomization list was provided to the researchers. In each of the 70 blocks are written two letters, a, two letters b, a which means intervention group and b means control group
Blinding (investigator's opinion)
Single blinded
Blinding description
The Study is a Blind One-Way study in which data analysts do not know about the drug used but researchers and patients are informed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani St., Shahrekord University of Medical Sciences, Ethics Committee of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-06-08, 1400/03/18
Ethics committee reference number
IR.SKUMS.REC.1400.074
Health conditions studied
1
Description of health condition studied
Major Depression , ECT
ICD-10 code
F99
ICD-10 code description
Mental disorder, Not Otherwise Specified
Primary outcomes
1
Description
Cognitive Disorders Score in Cognitive Status Assessment Questionnaire (MMSE Questionnaire)
Timepoint
Measurement of Cognitive Disorders before intervention and one month after consumption of Lemon Balm Capsules
Method of measurement
Cognitive Status Assessment Questionnaire (MMSE Questionnaire)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 32 depressed patients treated with ECT, receiving 320 mg lemon balm capsules (made by the researcher) twice a week every 12 hours and three times a week after ECT and after a Evaluation month with questionnaire
Category
Treatment - Drugs
2
Description
Control Group: 32 Depressed patients treated with ECT receiving oral capsules containing 320 mg twice a week every 12 hours and three times a week ECT and then one month evaluation with a questionnaire
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Majid Taheri
Street address
Hajar Hospital , Parastar St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817917546
Phone
+98 38 3338 8836
Email
Info@Skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Esfandiar Heydarian
Street address
Shahrekord University of Medical Sciences , Kashani St .
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Pajoohesh@Skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
50
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Massoud Nikfarjam
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hajar Hospital, Parastar St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Nikmas140@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Massoud Nikfarjam
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hajar Hospital, Parastar St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Nikmas140@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Kaviani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.12 Jihad Alvand St, Mirabad West
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817917546
Phone
+98 38 3338 8836
Email
FatemeKaviani950@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available