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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
Quercetin
Sponsored by
Hôpital Universitaire Sahloul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for a Randomized Double-blind Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riadh Boukef

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quercetix group

Placebo Group

Arm Description

Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal.

Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal.

Outcomes

Primary Outcome Measures

Number of patients
Number of patients attending the emergency room

Secondary Outcome Measures

disappearance of symptoms
Date of disappearance of symptoms present on admission
adverse reaction
Presence of an adverse reaction due to the administration of the treatment

Full Information

First Posted
February 6, 2021
Last Updated
January 2, 2023
Sponsor
Hôpital Universitaire Sahloul
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1. Study Identification

Unique Protocol Identification Number
NCT04851821
Brief Title
The Effectiveness of Phytotherapy in SARS-COV2(COVID-19)
Acronym
Quercetix
Official Title
The Effectiveness of Phytotherapy in the Treatment of SARS-COV2 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Sahloul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
a Randomized Double-blind Study, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), PHYTOTHERAPIE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quercetix group
Arm Type
Experimental
Arm Description
Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Each patient included, after signing the consent, will have a treatment for ten days: one tablet twice a day 30 minutes before the meal.
Intervention Type
Drug
Intervention Name(s)
Quercetin
Other Intervention Name(s)
PLACEBO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients
Description
Number of patients attending the emergency room
Time Frame
10 DAYS
Secondary Outcome Measure Information:
Title
disappearance of symptoms
Description
Date of disappearance of symptoms present on admission
Time Frame
10 days
Title
adverse reaction
Description
Presence of an adverse reaction due to the administration of the treatment
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riadh Boukef, professor
Organizational Affiliation
CHU Sahloul, Sousse, Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riadh Boukef
City
Sahloul
State/Province
Sousse
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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