Investigating the effect of Viola Odorata using a questionnaire (Beck) to investigate the improvement of mild to moderate depression
Design
Clinical trial with control and intervention group, based on community and practical, parallel and single-blinded and randomized on 60 patients.
Settings and conduct
In this clinical trial study, the effect of Viola Odorata syrup on mild depression of 60 patients will be examined. We select patients over 15 years of age who referred to the hospitals and clinics of Tehran Azad University and were diagnosed with mild to moderate depression. We will divide the patients into two groups, those receiving syrup containing Viola Odorata and those receiving placebo. All patients will receive a standard regimen containing SSRI antidepressants. In addition to the standard treatment, the experimental group will receive syrup containing Viola Odorata daily. The control group will receive a placebo instead of syrup containing Viola Odorata.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with mild to moderate depression over 15 years old.
exclusion criteria: Pregnant and Breast-feeding women and patients with liver and kidney failure.
Intervention groups
60 patients over 15 years old with mild to moderate depression, confirmed by a psychiatrist, will be selected. Half of these individuals, placed in the intervention group using a random number table, will receive SSRI medication and Viola Odorata syrup for a period of 3 months. The outcome variable will be assessed every two weeks after starting treatment. The other half of the study participants will be placed in the control group and will receive the SSRI medication, with the difference being that instead of Viola Odorata syrup, they will receive a placebo.
Main outcome variables
Improvement score in the Beck questionnaires
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N19
Registration date:2024-05-09, 1403/02/20
Registration timing:prospective
Last update:2024-05-09, 1403/02/20
Update count:0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The use of viola odorata syrup on depression in hospitals and clinics affiliated to the Islamic Azad University of Tehran
Public title
The use of viola odorata syrup on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minor to moderate depression disorder
Use of SSRIs by control group
Age range over 15 years
Exclusion criteria:
Pregnant women
Breast feeding women
GFR under 30 & child pugh B - C (Renal & Liver failure)
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the study, each patient is assigned a code(1 or 2) using Rand number. Conventionally, the patient who received code one will receive drug and the patient who received code two will receive placebo. It should be noted that the patients will not know what code they have received and only the researcher will be aware of this issue.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single blinded in such a way that the participants will not be aware of the contents of the medicine package they receive. A code will be assigned to each patient using Rand number. Patients with a code of 1 will receive the drug, while patients with a code of 2 will receive a placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق واحد علوم دارویی دانشگاه علوم پزشکی آزاد اسلامی تهران
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2023-12-27, 1402/10/06
Ethics committee reference number
IR.IAU.PS.REC.1402.554
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
Depression recovery degree according to Beck questionnaire
Timepoint
14 day
Method of measurement
Beck depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients over 15 years old with mild to moderate depression, confirmed by a psychiatrist, will be selected to use a Viola Odorata syrup made by Barij Essence Pharmaceutical Company once a day for a period of 3 months, in addition to taking an SSRI medication. Their improvement will be evaluated every two weeks through a Beck questionnaire.
Category
Treatment - Drugs
2
Description
Control group: 30 patients in the control group will receive the SSRI drug, similar to the intervention group. However, instead of receiving Viola Odorata syrup, they will receive a placebo syrup made by Barij Essence Pharmaceutical Company once a day for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali hospital
Full name of responsible person
Zeinab Nazari
Street address
Damavand street, not reaching Imam Hossein square, Bu Ali hospital
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Pharmaceutical company
Full name of responsible person
Laleh Hejazi
Street address
NO.78, Aryafar Ave., Marzdaran Blvd., Tehran Province
City
Tehran
Province
Tehran
Postal code
۱۴۶۴۶۵۳۴۷۱
Phone
+98 21 4426 7992
Email
crm@barijessence.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Pharmaceutical company
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal street, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2263 3986
Email
shiehmorteza@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No.99,Yakhchal Street., Dr shariati Ave.
City
تهران
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0056
Email
nazarizeynab32@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab Nazari
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal Ave , Dr Shariati Street.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2263 3986
Email
nazarizeynab32@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Data are collected in the form of a questionnaire
When the data will become available and for how long
After the intervention
To whom data/document is available
Qualified persons
Under which criteria data/document could be used
Use for scientific advancement in the field under study
From where data/document is obtainable
Clinical office of Islamic Azad University Medical science of Tehran -Faculty of Pharmacy
What processes are involved for a request to access data/document
Request in writing by going through legal procedures