Evaluating the effect of Phyllanthus Emblica on COVID 19 patients

Phase 3

• Conditions: COVID 19.; Corona virus infection, unspecified; U07.1

• Registration Number: IRCT20200404046937N2
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age =18 years
Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging
Hospitalized with: Fever (axillar or oral temperature = 38.0°) or Respiratory rate >24/min Or Cough
Less than 8 days since illness onset
Willingness of study participant to accept randomization to any assigned treatment arm
Acceptance of non-participation in another study before the 28th day of the study

Exclusion Criteria

Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Severe liver disease
Known allergic reaction to Phyllanthus Emblica
Severe renal impairment
Pregnant or breastfeeding women
Transfer to another non-study hospital within the next 72 hours
Receipt of any experimental treatment for COVID 19 within the 30 days prior to the time of the screening evaluation
Angiotensin converting enzyme (ACE) inhibitor user

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral diagnostic test. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Polymerase chain reaction.

Secondary Outcome Measures

Name	Time	Method
Fever. Timepoint: Daily. Method of measurement: Thermometer.;Chill. Timepoint: Daily. Method of measurement: Patients interview and patient file.;Cough. Timepoint: Daily. Method of measurement: Patients interview and patient file.;Dyspnea. Timepoint: Daily. Method of measurement: Patients interview and patient file.;Lymphocyte blood count. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Cell counter.;C_reactive protein. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: Agglutination kit.;Chest CT scan. Timepoint: The first day of the study and the end of the study (10th day). Method of measurement: CT scan set.