The Effectiveness of Phytotherapy in SARS-COV2(COVID-19) (Quercetix)

The Effectiveness of Phytotherapy in the Treatment of SARS-COV2 (COVID-19)

Quercetin is one of the flavonoids. Quercetin as well as rutin are recognized to be among the most active of the flavonoids. It is to quercetin that several medicinal plants, including ginkgo and St. John's Wort, owe part of their therapeutic effects. Often combined with vitamin C in supplements, it improves absorption by the body and delays its elimination.

Quercetin is extracted from a variety of plant sources, including the onion peel and seeds and pods of Dimorphandra mollis, a tree in the legume family native to South America.

At present, there is no scientific data to demonstrate the effectiveness of herbal medicine, regardless of the plant, to prevent or treat COVID-19. On the other hand, some plant-based food supplements have anti-inflammatory or immunomodulatory properties that may disrupt inflammatory defense mechanisms useful in fighting infections, and in particular against COVID-19.

Study Overview

• Status: Completed
• Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); a Randomized Double-blind Study; PHYTOTHERAPIE
• Intervention / Treatment: Drug: Quercetin

Detailed Description

Type of study: a randomized, double-blind study using the Quercetine in the treatment of patients with SARS COV2 (covid-19) Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America.

Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, and antihistamine (antiallergic) properties have been observed in numerous in vitro and animal studies.

History on quercetin In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name "vitamin P" because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Tunisia
  • Sousse
    • Sahloul, Sousse, Tunisia
      • Riadh Boukef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients attending the emergency department for influenza-like illness.
• Being over 18 years old

Exclusion Criteria:

• Any patient requiring admission
• Non-consenting patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quercetix group; Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal.	Drug: Quercetin; Each patient included, after signing the consent, will have a treatment for ten days: one tablet times three per day 30 minutes before the meal.; Other Names: PLACEBO
Placebo Comparator: Placebo Group; Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal.	Drug: Quercetin; Each patient included, after signing the consent, will have a treatment for ten days: one tablet times three per day 30 minutes before the meal.; Other Names: PLACEBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients	Number of patients attending the emergency room	10 DAYS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disappearance of symptoms	Date of disappearance of symptoms present on admission	10 days
adverse reaction	Presence of an adverse reaction due to the administration of the treatment	10 days

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Sahloul

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: Quercetix

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Statistical analysis Plan can be shared in supplimentary data
• IPD Sharing Time Frame: In the publication of the article
• IPD Sharing Access Criteria: we will publish the Access criteria after the final Statistical analysis
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No