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Treatment of Covid-19 With a Herbal Compound, Xagrotin

Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05017493
Enrollment
661
Registered
2021-08-24
Start date
2020-07-01
Completion date
2021-02-08
Last updated
2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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.

Detailed description

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.

Interventions

COMBINATION_PRODUCTXagrotin

A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care

Sponsors

Directorate of Health of Sulaimani, Iraq
CollaboratorOTHER
Biomad AS
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 or higher * Newly diagnosed (no longer than 10 days) * PCR or clinically confirmed Covid-19

Exclusion criteria

* Severe pulmonary disease * Severe cardiovascular disease * Severe hepatic disease * Severe renal disease * Diabetes mellitus type one * Metabolic acidosis * Oxygen saturation \<70% * Pregnancy * Breast feeding * Concomitant treatment with anticoagulation drugs * Concomitant treatment with CYP3A4 medicines with narrow therapeutic window

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 daysNumber of Participants who died by day 30 after the enrollment

Secondary

MeasureTime frameDescription
Duration of Disease From Beginning of Treatment30 daysNumber of days the patient has experienced the symptoms
Hospitalization30 daysNumber of participants who have been hospitalized for Covid-19
Duration of Hospitalization When Occurred30 daysDays the participants were hospitalized

Countries

Iraq

Participant flow

Recruitment details

All adult patients in an outpatient setting who were confirmed as coronavirus patients were eligible to be included in the study.

Pre-assignment details

Age 18 or higher, Newly diagnosed (no longer than 10 days), PCR or clinically confirmed Covid-19

Participants by arm

ArmCount
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
483
Control Arm
Patients in the Control arm received the standard of care for Covid19.
178
Total661

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision150
Overall StudyProtocol Violation810
Overall StudyWithdrawal by Subject260

Baseline characteristics

CharacteristicControl ArmTotalTreatment Arm
Age, Categorical
<=18 years
5 Participants28 Participants23 Participants
Age, Categorical
>=65 years
23 Participants86 Participants63 Participants
Age, Categorical
Between 18 and 65 years
150 Participants547 Participants397 Participants
Age, Continuous44.297 years
STANDARD_DEVIATION 17.16
44.1 years
STANDARD_DEVIATION 17.16
43.9 years
STANDARD_DEVIATION 17.16
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
178 Participants661 Participants483 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Iraq
178 participants661 participants483 participants
Sex: Female, Male
Female
91 Participants303 Participants212 Participants
Sex: Female, Male
Male
87 Participants358 Participants271 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 48310 / 178
other
Total, other adverse events
113 / 48315 / 178
serious
Total, serious adverse events
1 / 48310 / 178

Outcome results

Primary

Mortality

Number of Participants who died by day 30 after the enrollment

Time frame: 30 days

ArmMeasureValue (NUMBER)
Treatment ArmMortality2 participants
Control ArmMortality10 participants
Secondary

Duration of Disease From Beginning of Treatment

Number of days the patient has experienced the symptoms

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Treatment ArmDuration of Disease From Beginning of Treatment9.9 DaysStandard Deviation 5.5
Control ArmDuration of Disease From Beginning of Treatment18.1 DaysStandard Deviation 9.5
Secondary

Duration of Hospitalization When Occurred

Days the participants were hospitalized

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
Treatment ArmDuration of Hospitalization When Occurred5.56 DaysStandard Deviation 4.94
Control ArmDuration of Hospitalization When Occurred5.5 DaysStandard Deviation 3.42
Secondary

Hospitalization

Number of participants who have been hospitalized for Covid-19

Time frame: 30 days

ArmMeasureValue (NUMBER)
Treatment ArmHospitalization11 Participatnts
Control ArmHospitalization57 Participatnts

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026