Clinical Trial Information
Change Log
| Field Name | Value | |
|---|---|---|
| Trial Registration Id | SATR2492226 | |
| IRB number (Institutional Review Board) | 382593427 | |
| Date submitted | 01/01/2019 | |
| Date registered | 01/01/2019 | |
| Date last updated | 01/01/2019 | |
| Type of registration | ongoing | |
| Public title | Test | |
| Scientific title | Test | |
| UTN (Universal Trial Number) | 8237482397 | |
| Trial acronym | 2375298 | |
| Phase | not_applicable | |
| Health condition studied |
HCS HCS1 |
|
| Condition category | Alternative and complementary medicine | |
| Condition code | Herbal remedies | |
| Study type | interventional | |
| Study Design/Description of interventions/Exposure | Test | |
| Intervention code | not applicable | |
| Control treatment | No treatment | |
| Control group | Active | |
| Primary outcome Timepoint | POT | |
| Secondary outcome Timepoint | SOT | |
| Key inclusion area | KIC | |
| Minimum age | 12 | |
| Minimum age (unit) | Years | |
| Maximum age | 22 | |
| Maximum age (unit) | Years | |
| Gender | Male | |
| Key exclusion criteria | KEC | |
| Can healthy volunteers participate? | Yes | |
| Purpose of the study | Treatment | |
| Allocation to intervention | Randomised controlled trial | |
| Allocation concealment procedures | Concealed | |
| Sequence generation | SG | |
| Masking/blinding | Open (masking not used) | |
| Intervention assignment | Single group | |
| Other design feature | ODF | |
| Type of endpoint | Safety | |
| Statistical methods/analysis | SMA | |
| Recruitment status | Recruiting | |
| Date of first participant enrolment (Anticipated date) | 01/01/2019 | |
| Date of first participant enrolment (Actual date) | 12/01/2019 | |
| Date of last participant enrolment (Anticipated date) | 02/01/2019 | |
| Date of last participant enrolment (Actual date) | 15/01/2019 | |
| Date of last data collected (Anticipated date) | 03/01/2019 | |
| Date of last data collected (Actual date) | 20/01/2019 | |
| Target sample size | 12 | |
| Current sample size | 16 | |
| Recruiting in Saudi Arabia (Recruitment sites) | yes | |
| Recruitment hospitals | Test Hospital | |
| Outside Saudi Arabia (Recruitment sites) | no | |
| Funding source type | Government body | |
| Funding source name | Test | |
| Funding source address | Test | |
| Funding source country | Saudi Arabia | |
| Ethics application status | approved | |
| Ethics application approval date | 01/01/2019 | |
| Ethics committee | Test | |
| Ethics committee address | Saudi Arabia | |
| Ethics committee country | Saudi Arabia | |
| Ethics committee submit date | 01/01/2019 | |
| Ethics committee approve date | 09/01/2019 | |
| Ethics committee approve id | 12 | |
| Brief summary | Test Brief Summary | |
| Data sharing statement/Public notes | Test Public Notes | |
| Principal investigator information (title) | Mr. | |
| Principal investigator information (first name) | Test | |
| Principal investigator information (last name) | User | |
| Principal investigator information (address) | Saudi Arabia | |
| Principal investigator information (country) | Saudi Arabia | |
| Principal investigator information (number) | 2478236 | |
| Principal investigator information (email) | test@test.com | |
| Contact person for public queries (title) | Mr. | |
| Contact person for public queries (first name) | Test | |
| Contact person for public queries (last name) | User One | |
| Contact person for public queries (address) | Saudi Arabia | |
| Contact person for public queries (number) | 3248932784 | |
| Contact person for public queries (email) | test1@test.com | |
| Contact person for scientific queries (title) | Mr. | |
| Contact person for scientific queries (first name) | Test | |
| Contact person for scientific queries (last name) | User Three | |
| Contact person for scientific queries (address) | Saudi Arabia | |
| Contact person for scientific queries (number) | 93287492347 | |
| Contact person for scientific queries (email) | test2@test.com | |