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Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3

Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05222425
Enrollment
3000
Registered
2022-02-03
Start date
2022-06-01
Completion date
2022-12-07
Last updated
2022-03-17

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

Conditions

Sars-cov-2

Keywords

sars-cov-2

Brief summary

This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.

Detailed description

An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events will be registered.

Interventions

A herbal compound

DRUGGreen tea

Normal green tea

Sponsors

Biomad AS
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 daysNumber of Participants who die 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

Contacts

Primary ContactDana Omer, PhD
danaomar1979@gmail.com+9647701586707

Outcome results

None listed

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