Evaluation of the effectiveness of rhubarb and ox tongue combination syrup in patients with obsessivec ompulsive disorder
Design
This study is a double-blind randomized clinical trial that includes an intervention and treatment group. Information based on mild to moderate obsessive-compulsive disorder has been identified by DSM-5 criteria.The sample size was determined according to the information of similar studies such as the study of Sayyah et al. And also with the help of PASS software by observing power = 80%, α = 0.05 and D = 2. The number 30 was set for each group.
Settings and conduct
This study is a randomized and interventional clinical trial that includes an intervention and treatment group. Patients with obsessive-compulsive disorder is identified by 5-DSM criteria, patients before therapeutic intervention after obtaining consent based on Questionnaires are evaluated and statistically analyzed.
Participants/Inclusion and exclusion criteria
Obsessive-compulsive disorder with 16th grade Yale Brown Questionnaire, Age 18 beteween 50 years At least a diploma History Receive at least 20 hours of exposure and prevent continuous response (individual or group), history of taking at least two drugs withMaximum recommended dose for at least 12 weeks satisfaction with participating in research
Intervention groups
Patients with obsessive-compulsive disorder identified by DSM_5 criteria and age18_50
Main outcome variables
Intensity of obsessive-compulsive disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200712048088N1
Registration date:2020-12-06, 1399/09/16
Registration timing:retrospective
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
alaa masiha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 0699
Email address
dr.alaamasiha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-24, 1399/07/03
Expected recruitment end date
2020-11-23, 1399/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness syrup of rhubarb and ox tongue on patients with obsessive_ compulsive disorder mild to modrate
Public title
Evaluation of the effect of rhubarb syrup and ox tongue flower on clinical signs of obsessive-compulsive disorder
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Minimum diploma education
HistoryReceive at least 20 hours of exposure and prevent continuous response (individual or group)
History of taking at least two drugs withThe maximum recommended dose for at least 12 weeks
Satisfaction with participating in research.
Diagnosis of obsessive-compulsive disorder (OCD) with the 16th grade Yale Brown Questionnaire
Exclusion criteria:
Psychosis or bipolar disorder
Start a new psychological or psychiatric treatment or change the dose of medication,
Reluctance to continuetreatment
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants by statistical software
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad School of Medical Sciences
Street address
No 4 , Somayh 5 alley, Somayeh St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617669416
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.391
Health conditions studied
1
Description of health condition studied
obsessive-compulsive disorder mild to moderate
ICD-10 code
وسواس
ICD-10 code description
وسواس
Primary outcomes
1
Description
obsessive-compulsive disorder mild to modrate
Timepoint
Initial evaluation,4,6,8weeks later
Method of measurement
Bill Brown Obsessive compulsive disorder Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:syrup of rhubarb and ox tongue(borage) for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn sina hispital
Full name of responsible person
Doctor AliTalaei
Street address
Mashhad, Hor Amoli street, next to Astan Quds Razavi vehicle
City
MASHHAD
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
ebnesina.hos@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali talaei
Street address
Mashhad school of medicine, pardis of univercity ,Azadisquare,faculty of medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۹۱۹۹_۶۶۷۱۹
Phone
+98 51 3800 2495
Email
norasmr@mums.ac.ir
Web page address
https://www.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 univercity of medical scince
Full name of responsible person
Mohammadreza Noras
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad school of medicine, pardise University, Azadi square
City
Mashad
Province
Razavi Khorasan
Postal code
91778_99191
Phone
+98-51-38552188-9
Fax
+98 51 3853 5980
Email
NorasMR@mums.ac.ir
Web page address
http://tim.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Noras
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad shool of medicine ,Azadi squer,Pardis university
City
Mashhad
Province
Razavi Khorasan
Postal code
99199_91766
Phone
+98-51-38552188-9
Email
NorasMR@mums.ac.ir
Web page address
http://tim.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Lida Jarahi
Position
Asociated professor
Latest degree
Medical doctor
Other areas of specialty/work
Health Promotion
Street address
Mashhad school of medicine, pardis of univercity ,Azadisquare,faculty of medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
99199_66719
Phone
+98 51 3800 2495
Email
jarahil@mums.ac.ir
Web page address
http://tim.mums.ac.ir/
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
En Evaluation of the effectiveness syrup of rhubarb and ox tongue(borage)on patients with refractory obsessive-compulsive disorder
When the data will become available and for how long
2 years after graduation
To whom data/document is available
all the reaserchers
Under which criteria data/document could be used
There is not any considrable term
From where data/document is obtainable
دmashhadunivercity of medical science
What processes are involved for a request to access data/document