Unique trial number
Primary Registry and Trial Identification number
Name of Primary Registry, and the unique ID number assigned by the Primary Registry to this trial.
Trial registration date
Date of Registration in Primary Registry
Date when trial was officially registered in the Primary Registry.
Secondary identification number(s)
Other identifying numbers and issuing authorities besides the Primary Registry, if any.
Source(s) of Monetary or Material Support
Major source(s) of monetary or material support for the trial (e.g., funding agency, foundation, company).
The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a trial (including arrangements to ensure that the trial design meets appropriate standards and to ensure appropriate conduct and reporting).
Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship.
Responsible contact person
Contact for Public Queries
Email address, telephone number, or postal address of the contact who will respond to general queries, including information about current recruitment status
Research contact person
Contact for Scientific Queries
Email address, telephone number, or postal address, and affiliation of the person to contact for scientific queries about the trial.
Title of the study (brief title)
Title intended for the lay public in easily understood language.
Official scientific title of the study
Scientific title of the trial as it appears in the protocol submitted for funding and ethical review. Include trial acronym if available.
Research ethics review
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Countries of Recruitment
The countries from which participants will be, are intended to be, or have been recruited.
Health Condition(s) or Problem(s) Studied
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer, medication error).
Enter the specific name of the intervention(s) and the comparator/control(s) being studied. Use the International Non-Proprietary Name if possible. If the intervention consists of several separate treatments, list them all. For each intervention, describe other intervention details as applicable (dose, duration, mode of administration, etc).
Key inclusion and exclusion criteria
Key Inclusion and exclusion criteria
Inclusion and exclusion criteria for participant selection, including age and sex.
A single arm trial is one in which all participants are given the same intervention. A trial is "randomized" if participants are assigned to intervention groups using a method based on chance.
Anticipated trial start date
Date of First Enrollment
Anticipated or actual date of enrollment of the first participant.
Target sample size
Target Sample Size
Number of participants that this trial plans to enroll.
Recruitment status of this trial (e.g., pending, active, temporary halt, closed).
Outcomes are events, variables, or experiences that are measured because it is believed that they may be influenced by the intervention. The Primary Outcome should be the outcome used in sample size calculations, or the main outcome(s) used to determine the effects of the intervention(s). Enter the names of all primary outcomes in the trial as well as the pre-specified timepoint(s) of primary interest.
Key secondary outcomes
Key Secondary Outcomes
Secondary outcomes are events, variables, or experiences that are of secondary interest or that are measured at timepoints of secondary interest.