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

NCT04851821 | Completed Phase 1

• 1 other identifier: Quercetix
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

a Randomized Double-blind Study; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); PHYTOTHERAPIE

Outcome Measures

Primary Outcomes (1)

• Number of patients

  Number of patients attending the emergency room

  10 DAYS

Secondary Outcomes (2)

• disappearance of symptoms

  10 days

• adverse reaction

  10 days

Study Arms (2)

Quercetix group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Quercetin DRUG

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.

Also known as: PLACEBO

Placebo Group; Quercetix group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any patient requiring admission
• Non-consenting patients

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

Riadh Boukef

Sahloul, Sousse Governorate, Tunisia

Location

MeSH Terms

Interventions

Quercetin

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Riadh Boukef, professor

  CHU Sahloul, Sousse, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: April 20, 2021
• Study Start: January 4, 2021
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: In the publication of the article
• Access Criteria: we will publish the Access criteria after the final Statistical analysis

Locations

TU (1)