The Effect of Bombyx Mori Syrup - An Iranian Traditional Medicine Preparation - on Mild to Moderate Depression and Anxiety: a Triple-Blind Randomized Clinical Trial
The effect of bombyx mori syrup, an Iranian medicine preparation, on mild to moderate depression and anxiety.
Design
Patients were divided into control and intervention groups using block randomization model and were distributed in a three-blind study of Bombyx mori syrup and sertraline, without mentioning the name of the drug. The study duration for both groups will be 12 weeks. The sample size for each group will be 30 people.
Settings and conduct
This study is a triple blind randomized clinical trial. The sample of the study included patients with depression and anxiety who referred to the Urmia University of Medical Sciences Specialized Psychiatric Clinic in 2019.
Beck Depression Inventory and Beck Anxiety Inventory will be completed with patient information questionnaire. The study group received Bombyx mori syrup with Sertraline and the control group received Sertraline with Bombyx mori syrup placebo for 12 weeks. Patients will be followed up at 6 and 12 weeks and data will be analyzed.
Participants/Inclusion and exclusion criteria
Age range 18-60 years; at least two weeks of symptoms of depression and anxiety; no other mental illnesses; lack of physical disorders such as cancer, AIDS, diabetes, liver failure; Female patients; mild to moderate score from Beck Depression Inventory and Beck Anxiety Inventory
Intervention groups
The intervention group will be prescribed Bombyx mori syrup with sertraline and the control group will be given Bombyx mori syrup and sertraline for 12 weeks. Bombyx mori syrup will be given twice a day. Sertraline tablets will be given to both groups at a dose of 50mg.
Main outcome variables
Bombyx mori syrup effects on depression and anxiety symptoms of patients; depression and anxiety score of patients before and after Drugs change significantly; depression score and anxiety score of patients before and after Bombyx mori syrup and sertraline significantly.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190724044320N1
Registration date:2019-09-04, 1398/06/13
Registration timing:registered_while_recruiting
Last update:2019-09-04, 1398/06/13
Update count:0
Registration date
2019-09-04, 1398/06/13
Registrant information
Name
yahya zeynalpour fattahy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3338 0126
Email address
yahya.zeynalpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Bombyx Mori Syrup - An Iranian Traditional Medicine Preparation - on Mild to Moderate Depression and Anxiety: a Triple-Blind Randomized Clinical Trial
Public title
The Effect of Bombyx Mori Syrup - An Iranian Traditional Medicine Preparation - on Depression and Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
MADD for two weeks
Beck's Depression score: 14-28
Beck's Anxiety score: 8-25
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
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
Patients will be divided in two control and
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researcer,
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
University of Red Crescent - front of tax organization - kashani Ave. - Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715654868
Approval date
2019-01-09, 1397/10/19
Ethics committee reference number
IR.TUMS.VCR.REC.1397.739
Health conditions studied
1
Description of health condition studied
Depression and Anxiety
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Beck Depression Inventory score
Timepoint
Assessment of Beck Depression Inventory at baseline, 6 and 12 weeks after drug administration
Method of measurement
Beck Depression Inventory
2
Description
Beck Anxiety Inventory score
Timepoint
Assessment of Beck Anxiety Inventory at baseline, 6 and 12 weeks after drug administration
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be prescribed Bombyx Mori syrup with Sertraline tablets for 12 weeks. Bombyx Mori syrup will be given 5 cc (3grams) twice a day and Sertraline tablets will be administered at a dose of 50 mg daily. Sertraline are produced by Sobhan Pharmaceutical Company and Bombyx Mori syrup is manufactured by the Faculty of Pharmacy, Tehran University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: The control group will be prescribed sertraline tablets with Bombyx Mori syrup placebo for 12 weeks. Bombyx Mori syrup placebo will be given 5 cc (3grams) twice a day and Sertraline tablets will be administered at a dose of 50 mg daily. Sertraline are produced by Sobhan Pharmaceutical Company and Bombyx Mori syrup placebo is manufactured by the Faculty of Pharmacy, Tehran University of Medical Sciences.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Sciences
Full name of responsible person
Yahya Zeinalpour Fattahi
Street address
Tadbir Clinic, Ammar street, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5719654868
Phone
+98 44 3347 8547
Fax
+98 44 3346 0601
Email
yahya.zeynalpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Rezaizadeh
Street address
No. 27, North Sarparast Street, between Vesal and Palestine, West Taleghani Street, Tehran
City
Tehran
Province
Tehran
Postal code
5715654868
Phone
+98 21 8897 6527
Email
yahya.zeynalpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Yahya Zeinalpour Fattahi
Position
Assistant of Iranian traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian traditional medical faculty, Ahmadieh clinic, Sarparast st., Talegani Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 914 441 2701
Email
yahya.zeynalpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yahya Zeinalpour Fattahi
Position
Assistant of iranian traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian traditional medical faculty, Ahmadieh clinic, Sarparast st., Talegani Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 914 441 2701
Email
yahya.zeynalpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yahya Zeinalpour Fattahi
Position
Assistant of Iranian traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian traditional medical faculty, Ahmadieh clinic, Sarparast st., Talegani Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 914 441 2701
Email
yahya.zeynalpour@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
According of the rules of the faculty of Iranian traditional medicine of Tehran university of medical sciences
When the data will become available and for how long
Up to two years after the end of the study
To whom data/document is available
Researchers in academic and scientific institutions according of the rules of the Faculty of Iranian traditional medicine of Tehran university of medical sciences
Under which criteria data/document could be used
According of the rules governing scientific articles
From where data/document is obtainable
Faculty of Iranian traditional medicine of Tehran university of medical sciences and responsible for scientific accountability of the study
What processes are involved for a request to access data/document
According of the rules governing scientific articles
Comments
This study is a thesis approved by the faculty of Iranian medicine of Tehran university of medical sciences and it is subject to its laws regarding any publication, exploitation and other legal benefits.