Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    hesperidin | Covid19
Previous Study | Return to List | Next Study

Hesperidin and Diosmin for Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452799
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Kamal Mohammed Okasha, Tanta University

Brief Summary:
SARS-CoV-2 or COVID-19 is representing the major global burden that implicated more than 10 million infected cases and 500 thousand deaths worldwide. The prevalence of this pandemic disease is expected to rise every day. The challenge is to control its rapid spread meanwhile looking for a specific treatment to improve patient outcomes. Hesperidin is a classical herbal medicine used worldwide for a long time with an excellent safety profile. Hesperidin is a well-known herbal medication used as an antioxidant and anti-inflammatory agent. Available shreds of evidence support the promising use of hesperidin in prophylaxis and treatment of COVID 19. Herein, we discuss the possible prophylactic and treatment mechanisms of hesperidin based on previous and recent findings. Hesperidin can block coronavirus from entering host cells through ACE2 receptors which can prevent the infection. Anti-viral activity of hesperidin might constitute a treatment option for COVID-19 through improving host cellular immunity against infection and its good anti-inflammatory activity may help in controlling cytokine storm. Hesperidin mixture with diosmin co-administrated with heparin protect against venous thromboembolism which may prevent disease progression. Based on that, hesperidin might be used as a meaningful prophylactic agent and a promising adjuvant treatment option against SARS-CoV-2 infection.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Hesperidin and Diosmin mixture Early Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blind controlled Parallel study
Masking: Double (Participant, Care Provider)
Masking Description: Randomized double-blind controlled Parallel study
Primary Purpose: Treatment
Official Title: Randomized Double-blind Controlled Parallel Study of (Hesperidin and Diosmin Mixture) for Treatment of COVID-19 Newly Diagnosed Patients in Egypt
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: expermintal
1000mg of (Hesperidin and Diosmin mixture) three times daily for 7 days 1000mg of (Hesperidin and Diosmin mixture) two times daily for 3 days
Drug: Hesperidin and Diosmin mixture
Interventional Clinical Trial

Active Comparator: standard
standard care therapy in quarantine hospitals
Drug: Hesperidin and Diosmin mixture
Interventional Clinical Trial




Primary Outcome Measures :
  1. PCR test [ Time Frame: 14 days ]
    PCR negative


Secondary Outcome Measures :
  1. respiratory rate [ Time Frame: 14 days ]
    Changes in respiratory rate

  2. patients PaO2 [ Time Frame: 14 days ]
    Change in patients PaO2

  3. serum IL1β [ Time Frame: 14 days ]
    change in serum IL1β

  4. serum TNF-α [ Time Frame: 14 days ]
    changes in serum TNF-α

  5. Mortality rate [ Time Frame: 14 days ]
    decrease in Mortality rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Confirmed cases of Covid-19 (all by RT-PCR) Newly diagnosed asymptomatic or with upper respiratory tract infection (URTI) patients who will present with rhinitis, pharyngitis, or isolated low-grade fever and myalgia, Adult (18-65 Years old) Both sexes

Exclusion Criteria:

Patients with bleeding disorders Patients with low to very low blood pressure Patients after surgery Immunocompromised patients taking medication upon screening

Publications of Results:
Layout table for additonal information
Responsible Party: Prof. Dr. Kamal Mohammed Okasha, Professor, Tanta University
ClinicalTrials.gov Identifier: NCT04452799    
Other Study ID Numbers: 1111
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases