The possibility of using randomization in different groups of installation and holder placement was provided by Beck questionnaire at 0,2,4,6 weeks using questionnaaire
Settings and conduct
Patient admission in Sari Psychiatric Clinics and Imam Hossein Hospital in Sari
Patients with the Stritified Block Randomization method will be divided into two groups of 30 interventions and placebo. And blinding is two-way, and the drug capsule and control are similar, and patients and researchers are not aware of their type.
Participants/Inclusion and exclusion criteria
1.consent form 2.Age between 18 and 65 years 3.diagnose of depression disorder based on DSM5 and supervised for 6weeks
Exclosion: 1.The symptoms of high mood 2.Suicidal thoughts 3.Drug side effects 4.Pregnancy and breastfeeding
Intervention groups
Intervention Group: Eugenia Caryophillat,s product (Clove capsule) receive one capsule BD+ S Citalopram 20mg daily
Control group:placebo receive one capsule BD+ S Citalopram 20mg daily
Main outcome variables
score of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190309042979N1
Registration date:2020-05-04, 1399/02/15
Registration timing:retrospective
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
bita sadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4001
Email address
b.sadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-22, 1398/02/02
Expected recruitment end date
2020-04-02, 1399/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the therapeutic effect of Eugenia Caryophillat,s product in patients with depression
Public title
The effect of Eugenia Caryophillat,s product on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Declaration of written consent of the candidate for participation
18-65 years old
Detection of major depressive disorder based on DSM-5 and treated for more than 6 weeks
Score 14 to 28 in the depression test 21 BDI-II questions
Exclusion criteria:
symptoms of high mood
suicide incidence
The incidence of unknown side effect
patient request
pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to intervention and control groups
Stratified Block Randomization
Random number table
Patients with Stritified Block Randomization will be divided into two groups of 30 interventions and placebo. In this method, the group of mild to moderate depressed patients is classified as stritified. By randomly selecting the block, the number of patients is determined and the type of intervention is determined using closed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug of Intervention and placebo ,are coded in the envelope, patient and researcher and physician none of them don t khnow about them.drug and placebo are the same in colour and size and smell
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Khazar street
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.MAZUMS.REC.1398.302
Health conditions studied
1
Description of health condition studied
Major depressive disorder, single episode, moderate
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
2
Description of health condition studied
Major depressive disorder, single episode, mild
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
Depression Score
Timepoint
Before the start of the intervention (week 0) and 14, 28 and 42 days after the start of the intervention
Method of measurement
Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Eugenia Caryophillat,s product + S Citalopram - In this group, routine S-Sitalopram 20mg treatment daily one tablet plus clove product (Clove capsule) receive one capsule BD
Category
Treatment - Drugs
2
Description
Control group:placebo+s citalopram - In this group, routine treatment with 20 mg of s citalopram routine plus one pill daily plus placebo (placebo capsule) receive one capsule BD
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hossein hospital
Full name of responsible person
Dr jamal shams
Street address
Madani street
City
Tehran
Province
Tehran
Postal code
16177633141
Phone
+98 21 7755 8001
Fax
+98 21 7343 2396
Email
info@ehmc.ir
Web page address
http://www.ehmc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moalem Square. Deputy of research and technology. Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3304 4001
Fax
+98 11 3336 2569
Email
publicrel@mazums.ac.ir
Web page address
http://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
publicrel@mazums.ac.ir
Web page address
http://www.mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
publicrel@mazums.ac.ir
Web page address
http://www.mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Bita Sadeh
Position
Phd Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Khazar street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
bitasadeh7@gmail.com
Web page address
http://www.mazums.ac.ir/
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