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Hesperidin and Diosmin for Treatment of COVID-19

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ClinicalTrials.gov Identifier: NCT04452799
Recruitment Status : Unknown
Verified June 2020 by Prof. Dr. Kamal Mohammed Okasha, Tanta University.
Recruitment status was:  Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
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

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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

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

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:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases