Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease

NCT ID: NCT05157139

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-04-30

Brief Summary

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* The study is a randomized clinical trial to assess a natural formula of vanillin \& wheat germ oil to treat and stop the clinical progression of COVID-19.
* The study aims to treat people with mild-to-moderate COVID-19 before their cases become severe.
* The study duration is a 5-day experimental intervention and an extended 4 weeks follow up.

Detailed Description

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Conditions

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Mild-to-moderate COVID-19

Keywords

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mild-to-moderate COVID-19 vanillin, wheat germ oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Patients receiving only standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention (low dose)

Two capsules twice daily for 3 days then one capsule twice daily for 2 days

Group Type ACTIVE_COMPARATOR

Oral Capsule

Intervention Type DRUG

Oral Capsule of vanillin \& wheat germ oil

Intervention (high dose)

two capsules three times daily for 3 days, followed by one capsule three times daily for 4 days

Group Type ACTIVE_COMPARATOR

Oral Capsule

Intervention Type DRUG

Oral Capsule of vanillin \& wheat germ oil

Interventions

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Oral Capsule

Oral Capsule of vanillin \& wheat germ oil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. PCR confirmed diagnosis for COVID-19.
2. Age ≥18 years.
3. Both genders
4. The disease started within 7 days (ideally 72 hours) of diagnosis or clinical deterioration.
5. Patients diagnosed as mild or moderate

Exclusion Criteria

1. Patients diagnosed with severe Illness: Individuals who have SpO2 \<92% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mm Hg, respiratory frequency \>30 breaths/min, or lung infiltrates \>50%.
2. General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, and advanced cardiovascular diseases.
3. Allergy to Vanilla flavor, vanillin, or wheat germ oil
4. Active cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assoc. Prof. Ayman Ibrahim Baess

UNKNOWN

Sponsor Role collaborator

Dr. Noha Alaa Eldine Hassan Hamdy

UNKNOWN

Sponsor Role collaborator

Ph. Hanya Hesham Sweilam

UNKNOWN

Sponsor Role collaborator

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ibrahim ElMallah

Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ahmed I ElMallah, PhD

Role: primary

Other Identifiers

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0106922

Identifier Type: -

Identifier Source: org_study_id