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Treatment of Covid-19 With a Herbal Compound, Xagrotin

Phase 1
Completed
Conditions
Covid19
Registration Number
NCT05017493
Lead Sponsor
Biomad AS
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
661
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Mortality30 days

Number of Participants who died by day 30 after the enrollment

Secondary Outcome Measures
NameTimeMethod
Hospitalization30 days

Number of participants who have been hospitalized for Covid-19

Duration of Disease From Beginning of Treatment30 days

Number of days the patient has experienced the symptoms

Duration of Hospitalization When Occurred30 days

Days the participants were hospitalized

Trial Locations

Locations (1)

Directorate of health of Sulaimani, Iraq -KRG

🇮🇶

Sulaymaniyah, Iraq

Directorate of health of Sulaimani, Iraq -KRG
🇮🇶Sulaymaniyah, Iraq

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