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Trial details
Trial details
Rasha 123
Current status:
Approved
|
Date registered:
16/04/2020
|
Date last updated:
05/02/2020
Trial version(s)
History: 15/09/2018
History: 15/09/2018
History: 15/09/2018
History: 15/09/2018
Current: 15/09/2018
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2018090151
Protocol number
Rasha123
MOH registration number
20555/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
15/09/2018
Primary sponsor
Rasha
Primary sponsor: Country of origin
Lebanon
Public title
Rasha 123
Acronym
RH
Scientific title
Rasha 123
Acronym
RH
Brief summary of the study: English
Great Job
Brief summary of the study: Arabic
السجل الوطني للابحاث السريرية الاول من نوعه
Health conditions/problem studied: Specify
Heart Failure
Interventions: Specify
New medication
Key inclusion and exclusion criteria: Inclusion criteria
all adults
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
75
Key inclusion and exclusion criteria: Exclusion criteria
less than 18
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Non-randomized controlled trial
Study design: Masking
N/A
Study design: Control
Uncontrolled
Study phase
1 to 2
Study design: Purpose
Treatment
Study design: Assignment
Other
Study design: Specify assignment
single arm
IMP has market authorization
No
Name of IMP
In Love
Year of authorization
2014
Month of authorization
4
Type of IMP
Others
Type of IMP: Specify
chemical
Pharmaceutical class
heart diseases
Therapeutic indication
to treat heart failure
Therapeutic benefit
increase ejection fraction
Biospecimen retention
Samples without DNA
Biospecimen description
DNA saliva samples
Target sample size
1000
Actual enrollment target size
1
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
20/10/2018
Date of study closure: Type
Anticipated
Date of study closure: Date
20/10/2020
Recruitment status
Complete
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
I do not want to share
Additional data URL
later
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
KSA
25325
Sources of Monetary or Material Support
Name
King faisal hospital
Secondary Sponsors
Name
None
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rasha
Hamra
Beirut
Iceland
0255.0000
rasha@gmail
MOH
Scientific
Marie
Ok
Beirut
Lebanon
5655400000
marie@yahoo
MOH
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
AUB
RH
Oncologist
Approved
USJ
RH
Oncologist
NA
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
King faisal hospital
11/10/2018
RH
@gmail
565458
Makassed General Hospital
11/12/2019
RH
@yahoo
3336661
Countries of Recruitment
Name
Health Conditions or Problems Studied
Condition
Code
Keyword
heart failure
Heart failure (I50)
RF
Interventions
Intervention
Description
Keyword
pharmaceutical and behavioral
new medication with lifestyle changes
RH and forever
Primary Outcomes
Name
Time points
Measure
increast EF
in 6 months
EF
Key Secondary Outcomes
Name
Time points
Measure
I dont have
later
Ok
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
I added a new ethics review
09/12/2019
Download as PDF
Save a PDF copy of the summary of the trial