Extraction and preparing an oral dosage form of propolis
Evaluation of the depression score in the control group
Evaluation of the depression score in the treated group
Comparison of the depression score in the control and intervention group
Design
First phase: primary visit and examination
Second phase: visit and examination after weeks 1, 4 and 6
1- Drug group: The patients will take a SSRI drugs with Propolis ( 2000mg/70 kg) during 6 weeks.
2- Placebo group: The patients will take a SSRI drugs with placebo during 6 weeks.
Settings and conduct
Drug formulation will be done in Institute of Medicinal Plants. Clinical phase will be executed in psychiatrist's office.
According to literature we consider 68 patients that Stratified Randomly divided in control and study groups of 68 persons. Randomization will be done due to overcoming conflicts.
Blinding: Drug and placebo capsules have same size (00), color and weight. Both will be packed similarly with two codes A & B. Except project implementer else person Will not know drug codes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
individuals with diagnosis of mild-moderate depression according HDRS score
Age between 18-25
Outpatient
Exclusion criteria:
Diagnosis of another non-depression disorder for patient during study
Suicide inclination
The patient receive an antidepressant medication except SSRI
impossibility to track patient
Occurrence of side effects fever, digestive and heart complications followed by treatment
Intervention groups
The patients will divided into two groups randomly: first group take SSRI with 1g Propolis and second group will take same dosage of SSRI with placebo. HDRS questionnaire score will be examined by psychiatrist in 0, 2, 4 and 6 weeks after start of study.
Main outcome variables
Formulation and production of a new oral form of Propolis
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General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170311033004N2
Registration date:2018-08-29, 1397/06/07
Registration timing:prospective
Last update:2018-08-29, 1397/06/07
Update count:0
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Ali Razmi
Name of organization / entity
Academic Center for Education, Culture and Research
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4015
Email address
arazmi@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-01, 1397/07/09
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adjunctive therapy of propolis in the treatment of mild to moderate depression
Public title
Propolis effects on depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with diagnosis of mild-moderate depression according HDRS score
Age between 18-25
Outpatient
Patients with no comorbid disorders diabetes, high blood pressure or cardiovascular disease
Patients with no comorbid mental condition
No consumption drugs other than SSRI
Non-pregnant
Exclusion criteria:
Diagnosis of another non-depression disorder for patient during study
Suicide inclination
Taking anti depression medication except SSRI or electroconvulsive therapy
impossibility to track disease (absence at the time of visit, cancellation of the continuation of the study and death)
Occurrence of allergic reaction
Occurrence of some side effect disorders such as fever, digestive and heart complications due to drug intake
Hospitalization
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified randomization and Four unit blocks (AABB, ABAB. ABBA & etc.) will be used.
The selected stratifies are gender and the used medications.
SAS software will perform the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and the extract will filled in the same size (00) and same color capsules. The additive filler be applied to make same weight for the both. Only the main applicant are aware about the content of the pills.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Biomedical Research Ethics Committee
Street address
Darakeh street, Shahid Beheshti university
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.ACECR.Avicenna.REC.1396.30
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0, F32
ICD-10 code description
Depressive episode In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity. Capacity for enjoyment, interest, and concentration is reduced, and marked tiredness
Primary outcomes
1
Description
Formulation and primary sample
Timepoint
6 months
Method of measurement
quantitative
Secondary outcomes
1
Description
clinical trials
Timepoint
22th month
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Patients in this group will take a SSIRs anti-dep ression medicine with Propolis (2000mg/70kg) during 6 weeks
Category
Treatment - Drugs
2
Description
Control group: This group receives the previously prescribed medications and capsules contains placebo (lactose and breadcrumbs as fillers).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Ali Razmi
Street address
District 11, Karegar St, No. 606
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
Hosp_roozbeh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Academic Center for Education, Culture and Research (ACECR)
Full name of responsible person
Ali Razmi
Street address
Enghelab street, facing University of Tehran, central office
City
Tehran
Province
Tehran
Postal code
436414155
Phone
+98 21 6648 8515
Fax
+98 21 6648 8518
Email
secretariat@acecr.ac.ir
Web page address
http://acecr.ac.ir
Grant name
Grant code / Reference number
396000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Academic Center for Education, Culture and Research (ACECR)
Proportion provided by this source
100
Public or private sector
Private
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
Academic Center for Education, Culture and Research (ACECR)
Full name of responsible person
Ali Razmi
Position
Pharmacology phd
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Kamalshahr, Jahad daneshgahi research complex
City
Kamalshahr
Province
Alborz
Postal code
1689734337
Phone
+98 26 3476 4015
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute of Medicinal Plants (ACECR)
Full name of responsible person
Ali Razmi
Position
Pharmacology ,Phd
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Kamalshahr, Jahad daneshgahi research complex
City
Kamalshahr
Province
Alborz
Postal code
1689734337
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Institute of Medicinal Plants (ACECR)
Full name of responsible person
Ali Razmi
Position
Pharmacology/PhD
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Jahad daneshgahi complex
City
Kamalshahr
Province
Alborz
Postal code
1689734337
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
arazmi@alumnus.tums.ac.ir
Web page address
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
Results of this project will be published as an article and no individual data sharing is applicable.
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study protocol, statistical analysis plan, informed consent form and clinical study report will be available deidentified for other researchers .
When the data will become available and for how long
Immediately following publication; no end date
To whom data/document is available
Anyone
Under which criteria data/document could be used
The data is available for any analysis including reviews and meta-analyses.
From where data/document is obtainable
Data are available on the website of the journal which published the paper.
Also the mentioned data be available by contacting email arazmi@alumnus.tums.ac.ir .
What processes are involved for a request to access data/document
Proposals should be directed to arazmi@alumnus.tums.ac.ir. To access, data requestors will need send sign a data access agreement.