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

Sponsor
Hôpital Universitaire Sahloul (Other)
Overall Status
Completed
CT.gov ID
NCT04851821
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
5.8
Actual Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Phytotherapy in the Treatment of SARS-COV2 (COVID-19)
Actual Study Start Date :
Jan 4, 2021
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients [10 DAYS]

      Number of patients attending the emergency room

    Secondary Outcome Measures

    1. disappearance of symptoms [10 days]

      Date of disappearance of symptoms present on admission

    2. adverse reaction [10 days]

      Presence of an adverse reaction due to the administration of the treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riadh Boukef Sahloul Sousse Tunisia

    Sponsors and Collaborators

    • Hôpital Universitaire Sahloul

    Investigators

    • Principal Investigator: Riadh Boukef, professor, CHU Sahloul, Sousse, Tunisia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hôpital Universitaire Sahloul
    ClinicalTrials.gov Identifier:
    NCT04851821
    Other Study ID Numbers:
    • Quercetix
    First Posted:
    Apr 20, 2021
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Severe Acute Respiratory Syndrome
    Quercetin

    Study Results

    No Results Posted as of Jul 27, 2021