The effectiveness of herbal medicine (cuscuta epithymum) in clinical manifestations of patients with depression
Design
This study is a Phase 3 clinical trial with control group and randomization will be done using random number table. Sample size is 60
Settings and conduct
Mashhad Ebne Sina Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients at the age of 18 to 60 years with moderate depressive disorder based on DSM and tend to use herbal medicine. Non Inclusion criteria: patients with severe depression and lack of prominent medical disorder.
Intervention groups
Control group : Sertraline and placebo tablet are given in two doses in the morning and at night.
Intervention group: Sertraline tablets and herbal blend is given in two doses in the morning and at night.
The total study time is 6 weeks.
Main outcome variables
Depression severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171228038114N1
Registration date:2018-08-30, 1397/06/08
Registration timing:registered_while_recruiting
Last update:2018-08-30, 1397/06/08
Update count:0
Registration date
2018-08-30, 1397/06/08
Registrant information
Name
Sanaz Negahban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
sanaz1370negaban@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of herbal medicine (Cuscuta epithymum) on clinical manifestations of patients with depression
Public title
Effect of herbal medicine on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of depression by a psychiatrist
Age between 18 and 60
The tendency to use herbal medicine
Exclusion criteria:
Mild depression
Depression with psychotic symptoms
Pregnancy
Lactation
Alcohol addiction
Addiction
Thoughts and suicide
Drug addiction
Neurological disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
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
Simple randomization with random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participant, researcher and evaluator of research have been blind and they don't know that the drug is a placebo or the main drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Central building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.MUMS.fm.REC.1396.596
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
Severity of depression
Timepoint
At the beginning of the study, Week 6, Week 8
Method of measurement
Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The herbal drug (Cuscuta epithymum) and standard dose of sertraline are given to the patient. The herbal remedy and 50 mg sertraline tablets are given twice a day For a month.Herbal medicine is provided in the form of capsule formulated in the laboratory of the Mashhad Faculty of Medicine.
Category
Treatment - Drugs
2
Description
Control group: Sertraline and placebo are given at the same dose as the intervention group.The placebo and 50 mg sertraline tablets are given twice a day For a month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital
Full name of responsible person
Sanaz Negahban
Street address
Ibn Sina Hospital, Horre Ameli Street
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2001
Email
sanaz1370negahban@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tappaghdi
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388813944
Phone
+98 51 3841 3007
Email
tafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Noras
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Comprehensive Medicine, Ferdowsi University, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
913881-3944
Phone
+98 51 3882 9279
Email
norasmr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Talebi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-813944
Phone
+98 38413007051
Email
talebimh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sanaze Negahban
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3621 8474
Email
sanaz1370negahban@gmail.com
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