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Treatment of Covid-19 With a Herbal Compound, Xagrotin

NCT ID: NCT05017493

Last Updated: 2021-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

661 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-02-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.

Group Type EXPERIMENTAL

Xagrotin

Intervention Type COMBINATION_PRODUCT

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

Control arm

Patients in the Control arm received the standard of care for Covid19.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Xagrotin

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Directorate of Health of Sulaimani, Iraq

OTHER

Sponsor Role collaborator

Biomad AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Directorate of health of Sulaimani, Iraq -KRG

Sulaymaniyah, , Iraq

Site Status

Countries

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Iraq

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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02-032021-SULXAG/NO

Identifier Type: -

Identifier Source: org_study_id