Investigating the Effect of cinnamomum tamala on depression
Design
In this study, 50 patients with Major depression and Inclusion criteria referred to Tehran Psychiatric Institute are selected. The participants are randomly divided into intervention and control groups.Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
Tehran Psychiatric Institute
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Patients have MDD(Major Depression) diagnosis based on DSM5 and the maximum severity of depression is equal or higher than18in the Hamilton Depression Scale. Exclusion criteria: the presence of psychotic symptoms; the presence of another psychiatric disorder; receiving psychotropic drugs; receiving antidepressants in the past month and ECT in the last two months; hypothyroidism; history of cardiovascular disease, pregnancy or lactation
Intervention groups
Intervention: 25 people take 250 mg of cinnamomum tamala daily with Sertralin
Control group:25people take 250 mg of the plasebo daily with Sertralin
Main outcome variables
Severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037889N1
Registration date:2018-01-22, 1396/11/02
Registration timing:prospective
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
saloumeh ghafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5515 2192
Email address
ghaffari.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2018-06-30, 1397/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of oral administration of Cinnamomum tamala with placebo in patients with depressive disorder
Public title
Cinnamomum tamala in the treatment of major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: presence of Major Depressive Disorder based on DSM-5 criteria
baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 18
18-60 years old
Exclusion criteria:
Exclusion criteria: presence of psychosis
any other diagnosis in axis I and II;
receiving psychotropic medications
receiving any antidepressants during past one month or ECT during past two months;
hypothyroidism
cardiovascular problems
pregnancy or nursing women
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to intervention and control groups based on simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly divided into two groups and receive drug box with the same shape and size but different content,each patient is advised to take an oral capsule daily,the patient, the physician who will examine the patients and appraiser of them will not be aware of the contents of the drug containers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran, Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.IUMS.REC1396.9321309004
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major Depressive Disorder
Primary outcomes
1
Description
Depression score in Hamilton Test
Timepoint
2,4,6
Method of measurement
Hamilton Depression Test
Secondary outcomes
1
Description
Drug side effects
Timepoint
1,2,4,6,Weeks
Method of measurement
Drug side effects questionnaire
Intervention groups
1
Description
Intervention group: cinnamomum tamala 250-500 mg daily plus sertraline 50-100 mg / day
Category
Treatment - Drugs
2
Description
Control group: Placebo 250-500 mg daily with sertraline 50-100 mg / day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Psychiatric Institute
Full name of responsible person
Saloumeh Ghaffari
Street address
Faculty of Iranian Medicine,Behesht Street,Hassan Abad Square,Tehran
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Email
dr.salomehghafari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakoti
Street address
Iran University of Medical Sciences,Besides Milad Tower,Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
dr.salomehghafar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Saloumeh Ghaffari
Position
Student of PHD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine,Behesht St,Tehran
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Email
dr.salomehghafari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saloumeh Ghaffari
Position
Student of PHD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
847, Behest Street, Vahdat Islami Street,Hassan abad Square
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2192
Fax
Email
ghaffari.s@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saloumeh Ghaffari
Position
Student of PHD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
847, Behest Street, Vahdat Islami Street,Hassan abad Square
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2192
Fax
Email
ghaffari.s@tak.iums.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