An oral formula of vanillin and wheat germ oil for treatment of mild and moderate COVID-19 viral disease: a randomized controlled trial
Sweilam, H., Hamdy, N., Baess, A., El-Mallah, A. (2025). An oral formula of vanillin and wheat germ oil for treatment of mild and moderate COVID-19 viral disease: a randomized controlled trial. EKB Journal Management System, 2(1), 1-16. doi: 10.21608/japs.2024.286753.1026
Hanya Hesham Sweilam; Noha Alaa Hamdy; Ayman Ibrahim Baess; Ahmed Ibrahim El-Mallah. "An oral formula of vanillin and wheat germ oil for treatment of mild and moderate COVID-19 viral disease: a randomized controlled trial". EKB Journal Management System, 2, 1, 2025, 1-16. doi: 10.21608/japs.2024.286753.1026
Sweilam, H., Hamdy, N., Baess, A., El-Mallah, A. (2025). 'An oral formula of vanillin and wheat germ oil for treatment of mild and moderate COVID-19 viral disease: a randomized controlled trial', EKB Journal Management System, 2(1), pp. 1-16. doi: 10.21608/japs.2024.286753.1026
Sweilam, H., Hamdy, N., Baess, A., El-Mallah, A. An oral formula of vanillin and wheat germ oil for treatment of mild and moderate COVID-19 viral disease: a randomized controlled trial. EKB Journal Management System, 2025; 2(1): 1-16. doi: 10.21608/japs.2024.286753.1026

An oral formula of vanillin and wheat germ oil for treatment of mild and moderate COVID-19 viral disease: a randomized controlled trial

Journal of Advanced Pharmaceutical Sciences
Volume 2, Issue 1, January 2025, Page 1-16  XML PDF (976.17 K)
Document Type: Original Article
DOI: 10.21608/japs.2024.286753.1026
View on SCiNiTO View on SCiNiTO
Authors
Hanya Hesham Sweilam1; Noha Alaa Hamdy email orcid 2; Ayman Ibrahim Baessorcid 3; Ahmed Ibrahim El-Mallah4
1Clinical Pharmacist at Alexandria Main University Hospital
2Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Alexandria University
3Chest Department, Faculty of Medicine, Alexandria University
4Pharmacology & Toxicology Department, Faculty of Pharmacy, Alexandria University
Abstract
The world has been suffering from the consequences of COVID-19. Our study aimed to determine the efficacy of 5-day treatment course of wheat germ oil-vanillin mix for outpatients with mild to moderate COVID-19 symptoms.
Positive COVID-19 patients presented with symptoms within 7 days, were randomized into control and treatment arms. The treatment arm received the capsule and standard-of-care therapy (SOC) while the control arm received SOC only. All patients were followed up for 30 days. Symptoms were assessed based on the FDA-assessment of COVID-19 symptoms. The scoring system was used to assess the severity of symptoms. Blood samples were obtained for CBC and CRP analysis. A total of 61 patients were enrolled in the study. Patients in the treatment arm showed a significant improvement in disease severity when compared to the control arm (68.32% vs 30% reduction in symptoms at day 3, p<0.001). Time for recovery was significantly shorter in patients receiving treatment (p<0.001). No significant side effects were reported in either arm.
The herbal mix showed potential activity against COVID-19 and further assessment is recommended as a safe and affordable add-on therapy for inflammatory conditions.
The protocol was approved by the ethics committee of Alexandria University, protocol-ID:0106922. Trial registration: ClinicalTrials.gov.ID (NCT05157139).
Keywords
COVID-19; Germ oil; Herbs; Respiratory symptoms; Vanillin
Supplementary Files
References
  1. Wang H, Li X, Li T, Zhang S, Wang L, Wu X, et al.. The genetic sequence, origin, and diagnosis of SARS-CoV-2. 2020;39(9):1629-35.
  2. WHO SAJWHO. WHO coronavirus disease (COVID-19) dashboard. 2020.
  3. Alimohamadi Y, Sepandi M, Taghdir M, Hosamirudsari H. Determine the most common clinical symptoms in COVID-19 patients: a systematic review and meta-analysis. J Prev Med Hyg. 2020 Sep;61(3):E304-e12.
  4. Bohn MK, Hall A, Sepiashvili L, Jung B, Steele S, Adeli K. Pathophysiology of COVID-19: Mechanisms Underlying Disease Severity and Progression. Physiology (Bethesda). 2020 Sep 1;35(5):288-301.
  5. Kim JS, Lee JY, Yang JW, Lee KH, Effenberger M, Szpirt W, et al.. Immunopathogenesis and treatment of cytokine storm in COVID-19. Theranostics. 2021;11(1):316-29.
  6. Felsenstein S, Herbert JA, McNamara PS, Hedrich CM. COVID-19: Immunology and treatment options. Clinical Immunology. 2020 2020/06/01/;215:108448.
  7. Cauchois R, Koubi M, Delarbre D, Manet C, Carvelli J, Blasco VB, et al.. Early IL-1 receptor blockade in severe inflammatory respiratory failure complicating COVID-19. Proc Natl Acad Sci U S A. 2020 Aug 11;117(32):18951-3.
  8. Klinger JM, Ravarani CNJ, Bannard C, Lamparter M, Schwinges A, Cope JL, et al.. Critically ill COVID-19 status associated trait genetics reveals CDK6 inhibitors as potential treatment. 2021.
  9. Ochsner SA, Pillich RT, McKenna NJ. Consensus transcriptional regulatory networks of coronavirus-infected human cells. Sci Data. 2020 Sep 22;7(1):314.
  10. Choudhury A, Mukherjee S. In silico studies on the comparative characterization of the interactions of SARS-CoV-2 spike glycoprotein with ACE-2 receptor homologs and human TLRs. J Med Virol. 2020 Oct;92(10):2105-13.
  11. Na-Bangchang K, Porasuphatana S, Karbwang J. Perspective: repurposed drugs for COVID-19. Arch Med Sci. 2022;18(5):1378-91.
  12. Ghafoor K, Özcan M, Al Juhaimi F, Babiker E, Sarker MZ, Mohamed Ahmed I, et al.. Nutritional Composition, Extraction and Utilization of Wheat Germ Oil: A Review. European Journal of Lipid Science and Technology. 2016 12/01;119.
  13. Panel CJHN, editor: In. Coronavirus disease 2019 (COVID-19) treatment guidelines. 2020.
  14. Elwakil B, Shaaban M, Bekhit A, El-Naggar M, Olama Z. Potential anti-COVID-19 activity of Egyptian propolis using computational modeling. Future Virology. 2021 02/01.
  15. Sands JA. Inactivation and inhibition of replication of the enveloped bacteriophage phi6 by fatty acids. Antimicrobial agents and chemotherapy. 1977 1977/10//;12(4):523-8.
  16. A, Arafat RA. Ameliorative Effect of Wheat Germ Oil in Potassium bromate Induced Biochemical and Histopathological Changes in Male Rat's Heart. International Journal of Pharmaceutical And Phytopharmacological Research. 2019;9(5):126-31.
  17. Aziza S, Hussein S, Abdel-Aal SA, Elghwab AIM. Biochemical role of wheat germ oil on biomarkers of oxidative stress and inflammatory response in a rat model of endotoxemia. BENHA VETERINARY MEDICAL JOURNAL. 2014 12/01;27:157‐67.
  18. Yousuf M, Shamsi A, Queen A, Shahbaaz M, Khan P, Hussain A, et al.. Targeting cyclin-dependent kinase 6 by vanillin inhibits proliferation of breast and lung cancer cells: Combined computational and biochemical studies. J Cell Biochem. 2021 Aug;122(8):897-910.
  19. Peng Y, Liu L, Wang Y, Yao J, Jin F, Tao T, et al.. Treatment with toll-like receptor 2 inhibitor ortho-vanillin alleviates lipopolysaccharide-induced acute kidney injury in mice. Exp Ther Med. 2019 Dec;18(6):4829-37.
  20. Arya S, Rookes J, Cahill D, Lenka S. Vanillin: a review on the therapeutic prospects of a popular flavouring molecule. Advances in Traditional Medicine. 2021 01/07;21.
  21. Mai CW, Kang YB, Hamzah AS, Pichika MR. Comparative efficacy of vanilloids in inhibiting toll-like receptor-4 (TLR-4)/myeloid differentiation factor (MD-2) homodimerisation. Food Funct. 2018 Jun 20;9(6):3344-50.
  22. Masoud H, Elassal G, Zaky S, Baki A, Ibrahem H, Amin W, et al.. Management Protocol for COVID-19 Patients Version 1.4/30th May 2020 Ministry of health and population (MOHP), Egypt. 2020.
  23. Food, Administration D. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment, 2020. 2021.
  24. Inoue H. Overview of Automated Hematology Analyzer XE-2100™. Sysmex Journal International. 1999;9(1; SEAS SUM):58-64.
  25. Scharnhorst V, Noordzij PG, Lutz A, Graser U, Püntener D, Alquézar-Arbé A. A multicenter evaluation of a point of care CRP Test. Clin Biochem. 2019;71:38-45.
  26. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama. 2013 Nov 27;310(20):2191-4.
  27. WHO Guidelines Approved by the Guidelines Review Committee. Therapeutics and COVID-19: living guideline. Geneva: World Health Organization © World Health Organization 2021.; 2022.
  28. Le RQ, Li L, Yuan W, Shord SS, Nie L, Habtemariam BA, et al.. FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome. Oncologist. 2018 Aug;23(8):943-7.
  29. World Health Organization. Research guidelines for evaluating the safety and efficacy of herbal medicines:. WHO Regional Office for the Western Pacific. 1993.
  30. World Health Organization. Guidelines for the assessment of herbal medicines. World Health Organization. 1991.
  31. Calixto JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz J Med Biol Res. 2000;33:179–89.
  32. Egyptian Drug Authority. Egyptian Guidelines for Registration of Herbal Medicines: Egyptian Drug Authority, Central Administration for Pharmaceutical products; 2021.
  33. Ahmed S, Karim MM, Ross AG, Hossain MS, Clemens JD, Sumiya MK, et al.. A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness. International Journal of Infectious Diseases. 2021;103:214-6.
  34. Reis G, Silva EASM, Silva DCM, Thabane L, Milagres AC, Ferreira TS, et al.. Effect of Early Treatment with Ivermectin among Patients with Covid-19. 2022;386(18):1721-31.
  35. Kariyawasam JC, Jayarajah U, Riza R, Abeysuriya V, Seneviratne SL. Gastrointestinal manifestations in COVID-19. Trans R Soc Trop Med Hyg. 2021 Dec 2;115(12):1362-88.
 

 

Statistics
Article View: 219
PDF Download: 173