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| Name | Class |
|---|---|
| Directorate of Health of Sulaimani, Iraq | OTHER |
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This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. |
|
| Control arm | No Intervention | Patients in the Control arm received the standard of care for Covid19. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xagrotin | Combination Product | A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of Participants who died by day 30 after the enrollment | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Disease From Beginning of Treatment | Number of days the patient has experienced the symptoms | 30 days |
| Hospitalization | Number of participants who have been hospitalized for Covid-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Directorate of health of Sulaimani, Iraq -KRG | Sulaymaniyah | Iraq |
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Age 18 or higher, Newly diagnosed (no longer than 10 days), PCR or clinically confirmed Covid-19
All adult patients in an outpatient setting who were confirmed as coronavirus patients were eligible to be included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care |
| FG001 | Control Arm | Patients in the Control arm received the standard of care for Covid19. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Both paitients who received and NOT received Xagrotin
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Number of Participants who died by day 30 after the enrollment | Posted | Number | participants | 30 days |
|
30 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Xagrotin | Blood and lymphatic system disorders | Non-systematic Assessment | Xagrotin is a herbal compound, and it contains flavonoids, phenols, etc., which dilate blood vessels. Therefore, the risk of internal bleeding is higher in people who take high-dose vasodilators and high-dose Xagrotin at the same time. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Participants got Diarrhea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dara Omer | Hiwa Hospital - KRG | +9647701586707 | mailto:danaomar1979@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2021 | Nov 30, 2021 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2021 | Nov 30, 2021 | SAP_004.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 30 days |
| Duration of Hospitalization When Occurred | Days the participants were hospitalized | 30 days |
| Protocol Violation |
|
Patients in the Control arm received the standard of care for Covid19. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Duration of Disease From Beginning of Treatment | Number of days the patient has experienced the symptoms | Posted | Mean | Standard Deviation | Days | 30 days |
|
|
|
| Secondary | Hospitalization | Number of participants who have been hospitalized for Covid-19 | Posted | Number | Participatnts | 30 days |
|
|
|
| Secondary | Duration of Hospitalization When Occurred | Days the participants were hospitalized | Posted | Mean | Standard Deviation | Days | 30 days |
|
|
|
| 2 |
| 483 |
| 1 |
| 483 |
| 113 |
| 483 |
| EG001 | Control Arm | Patients in the Control arm received the standard of care for Covid19. | 10 | 178 | 10 | 178 | 15 | 178 |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment | Participants got flatulence |
|
All PIs discuss or publish the results only according to a prior agreement with the sponsor.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |