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All Studies   Meta Analysis    Recent:   

The effect of Nigella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 patients: A randomized controlled clinical trial

Said et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.1011522, NCT04981743
Nov 2022  
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Recovery, dyspnea 42% Improvement Relative Risk Recovery, D+NS, dyspnea 89% Recovery, cough 52% Recovery, D+NS, cough 77% Recovery, fatigue 56% Recovery, D+NS, fatigue 90% Recovery, smell 33% Recovery, D+NS, smell 67% Recovery, taste -25% Recovery, D+NS, taste 58% Recovery, sore throat 56% Recovery, D+NS, sore thr.. 86% Recovery, headache -175% Recovery, D+NS, headache 56% Recovery, diarrhea 87% Recovery, D+NS, diarrhea 90% Viral clearance, day 14 49% Viral clearance, day 7 23% Viral clearance, D+NS, d.. 91% Viral clearance, D+N.. (b) 87% Vitamin D  Said et al.  EARLY TREATMENT  RCT Is early treatment with vitamin D beneficial for COVID-19? RCT 60 patients in Egypt (July - December 2021) Improved recovery (p=0.57) and viral clearance (p=0.2), not sig. c19early.org Said et al., Frontiers in Pharmacology, Nov 2022 Favorsvitamin D Favorscontrol 0 0.5 1 1.5 2+
Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020
 
*, now with p < 0.00000000001 from 122 studies, recognized in 9 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 102 treatments. c19early.org
120 patient RCT comparing vitamin D, nigella sativa, and combined vitamin D+nigella sativa, showing improved symptom recovery and viral clearance with both vitamin D and nigella sativa, and further improvements with the combination of both. All patients received vitamin C, zinc, and lactoferrin.
This is the 24th of 30 COVID-19 RCTs for vitamin D, which collectively show efficacy with p=0.0000032.
This is the 100th of 122 COVID-19 controlled studies for vitamin D, which collectively show efficacy with p<0.0000000001 (1 in 587 sextillion).
Study covers nigella sativa and vitamin D.
risk of no recovery, 42.0% lower, OR 0.58, p = 0.57, treatment 30, control 30, adjusted per study, multivariable, dyspnea, RR approximated with OR.
risk of no recovery, 89.0% lower, OR 0.11, p = 0.01, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, dyspnea, RR approximated with OR.
risk of no recovery, 52.0% lower, OR 0.48, p = 0.16, treatment 30, control 30, adjusted per study, multivariable, cough, RR approximated with OR.
risk of no recovery, 77.0% lower, OR 0.23, p = 0.01, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, cough, RR approximated with OR.
risk of no recovery, 56.0% lower, OR 0.44, p = 0.20, treatment 30, control 30, adjusted per study, multivariable, fatigue, RR approximated with OR.
risk of no recovery, 90.0% lower, OR 0.10, p < 0.001, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, fatigue, RR approximated with OR.
risk of no recovery, 33.0% lower, OR 0.67, p = 0.67, treatment 30, control 30, adjusted per study, multivariable, smell, RR approximated with OR.
risk of no recovery, 67.0% lower, OR 0.33, p = 0.23, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, smell, RR approximated with OR.
risk of no recovery, 25.0% higher, OR 1.25, p = 0.79, treatment 30, control 30, adjusted per study, multivariable, taste, RR approximated with OR.
risk of no recovery, 58.0% lower, OR 0.42, p = 0.28, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, taste, RR approximated with OR.
risk of no recovery, 56.0% lower, OR 0.44, p = 0.36, treatment 30, control 30, adjusted per study, multivariable, sore throat, RR approximated with OR.
risk of no recovery, 86.0% lower, OR 0.14, p = 0.03, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, sore throat, RR approximated with OR.
risk of no recovery, 175.0% higher, OR 2.75, p = 0.13, treatment 30, control 30, adjusted per study, multivariable, headache, RR approximated with OR.
risk of no recovery, 56.0% lower, OR 0.44, p = 0.21, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, headache, RR approximated with OR.
risk of no recovery, 87.0% lower, OR 0.13, p = 0.05, treatment 30, control 30, adjusted per study, multivariable, diarrhea, RR approximated with OR.
risk of no recovery, 90.0% lower, OR 0.10, p = 0.03, treatment 30, control 30, adjusted per study, vitamin D and nigella sativa, multivariable, diarrhea, RR approximated with OR.
risk of no viral clearance, 49.0% lower, OR 0.51, p = 0.20, treatment 30, control 30, day 14, RR approximated with OR.
risk of no viral clearance, 23.0% lower, OR 0.77, p = 0.74, treatment 30, control 30, day 7, RR approximated with OR.
risk of no viral clearance, 91.0% lower, OR 0.09, p < 0.001, treatment 30, control 30, vitamin D and nigella sativa, day 14, RR approximated with OR.
risk of no viral clearance, 87.0% lower, OR 0.13, p = 0.003, treatment 30, control 30, vitamin D and nigella sativa, day 7, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Said et al., 8 Nov 2022, Randomized Controlled Trial, Egypt, peer-reviewed, 5 authors, study period 21 July, 2021 - 30 December, 2021, dosage 2,000IU daily, trial NCT04981743 (history). Contact: nagwa.sabri@pharma.asu.edu.eg.
This PaperVitamin DAll
The effect of Nigella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 patients: A randomized controlled clinical trial
Shimaa A Said, Alsayyed Abdulbaset, Amal A El-Kholy, Osama Besckales, Nagwa A Sabri
Frontiers in Pharmacology, doi:10.3389/fphar.2022.1011522
Background: The coronavirus disease 2019 (COVID-19) is a novel coronavirus that causes severe infection in the respiratory system. Since the immune status plays an essential role in combating COVID-19, herbal medicines, which have an immunomodulatory effect, may help prevent and even treat COVID-19. Nigella sativa is one of the herbal medicines with antiviral and immunomodulatory activities, and its therapeutic effectiveness makes it a promising add-on therapy for COVID-19. In addition, vitamin D3 has an immunomodulatory role, but the effect of therapeutic vitamin D3 supplementation in SARS-CoV-2 infection is still not well-known. Objective: This study aims to investigate the effects of Nigella sativa and vitamin D3 as single supplemental therapies and in combination on viral clearance indicated by a negative polymerase chain reaction and the alleviation of symptoms during the study follow-up duration of 14 days. Patients and Methods: The study design was an open-label randomized controlled clinical trial conducted at the Respiratory Hospital at the Kobry El Qobba Armed Forces Medical Complex. In total, 120 COVID-19 patients with mild to moderate symptoms were randomly assigned to four groups, with thirty patients each, as follows: Group 1 received an oral dose of 900 mg Nigella sativa through 450 mg soft gelatin capsules twice daily for two weeks; Group 2 received 2,000 IU of vitamin D3 through 1000-IU tablets given as two tablets, once daily; Group 3 received 900 mg of Nigella sativa and 2,000 IU of vitamin D3 in the same manner of dosing as in the previous groups; and Group 4 was the control group. All groups received standard therapy for COVID-19 infections and clinical management of COVID-19's clinical symptoms. Results: The Nigella sativa-vitamin D3 combination in addition to the standard therapy for COVID-19 infections significantly contributed to the alleviation of most COVID-19 symptoms: 50% of patients were free of cough after 7 days,
Ethics statement The studies involving human participants were reviewed and approved by the Ethics Committee, Faculty of Pharmacy, Ain Shams University, registered at the Egyptian Ministry of Health (MOH). The study was registered on clinicaltrials.gov (NCT ID: NCT04981743). Author contributions SS and NS formulated the research question. SS performed all the aspects of the clinical trial including acquiring the investigational agents and randomized the patients into treatment groups, data recording, and quality checks. OB and AA followed up patients and monitored for treatment efficacy and safety of investigational agents and reported study outcomes and clinical endpoints to the principal investigator. NS supervised all aspects of this study and provided guidance. AE-K supervised the quality of data. All the authors contributed equally to writing and revising the manuscript. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors, and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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' '<jats:italic>Nigella</jats:italic><jats:italic>sativa</jats:italic> is one of the herbal ' 'medicines with antiviral and immunomodulatory activities, and its therapeutic effectiveness ' 'makes it a promising add-on therapy for COVID-19. In addition, vitamin D3 has an ' 'immunomodulatory role, but the effect of therapeutic vitamin D3 supplementation in SARS-CoV-2 ' 'infection is still not well-known.</jats:p><jats:p><jats:bold>Objective:</jats:bold> This ' 'study aims to investigate the effects of <jats:italic>Nigella sativa</jats:italic> and ' 'vitamin D3 as single supplemental therapies and in combination on viral clearance indicated ' 'by a negative polymerase chain reaction and the alleviation of symptoms during the study ' 'follow-up duration of 14\xa0days.</jats:p><jats:p><jats:bold>Patients and ' 'Methods:</jats:bold> The study design was an open-label randomized controlled clinical trial ' 'conducted at the Respiratory Hospital at the Kobry El Qobba Armed Forces Medical Complex. In ' 'total, 120 COVID-19 patients with mild to moderate symptoms were randomly assigned to four ' 'groups, with thirty patients each, as follows: Group 1 received an oral dose of 900\xa0mg ' '<jats:italic>Nigella sativa</jats:italic> through 450\xa0mg soft gelatin capsules twice daily ' 'for two weeks; Group 2 received 2,000 IU of vitamin D3 through 1000-IU tablets given as two ' 'tablets, once daily; Group 3 received 900\xa0mg of <jats:italic>Nigella sativa</jats:italic> ' 'and 2,000 IU of vitamin D3 in the same manner of dosing as in the previous groups; and Group ' '4 was the control group. All groups received standard therapy for COVID-19 infections and ' 'clinical management of COVID-19’s clinical ' 'symptoms.</jats:p><jats:p><jats:bold>Results:</jats:bold> The <jats:italic>Nigella ' 'sativa</jats:italic>–vitamin D3 combination in addition to the standard therapy for COVID-19 ' 'infections significantly contributed to the alleviation of most COVID-19 symptoms: 50% of ' 'patients were free of cough after 7\xa0days, 70% showed an absence of fatigue after 4\xa0' 'days, 80% had no headache after 5\xa0days, 90% were free of rhinorrhea after 7\xa0days, and ' '86.7% of the patients had no dyspnea after 7\xa0days. Moreover, patients in the four studied ' 'groups showed a reduced median temperature after 3\xa0days of treatment. Negative results of ' 'the polymerase chain reaction (PCR) test recorded on the 7th and 14th\xa0day of therapy were ' 'superior in the <jats:italic>Nigella sativa</jats:italic> and vitamin D3 combination arm ' 'compared to those of the other studied arms where the value of the odds ratio (OR) on the ' '7th\xa0day was 0.13 with 95% CI: 0.03–0.45 and that of the 14th day was 0.09 with 95% CI: ' '0.02–0.3.</jats:p><jats:p><jats:bold>Conclusion:</jats:bold> The results of this study showed ' 'a promising therapeutic benefit of the administration of <jats:italic>Nigella ' 'sativa</jats:italic> and vitamin D3 combination in COVID-19 patients with mild to moderate ' 'symptoms. Additionally, the remarkable viral clearance in a short time interval and reduction ' 'in the severity and progression of symptoms recommended the use of this combination as an ' 'add-on therapy for the management of COVID-19 patients.</jats:p><jats:p><jats:bold>Clinical ' 'Trial Registration:</jats:bold><jats:ext-link>ClinicalTrials.gov</jats:ext-link>, Identifier: ' 'NCT04981743.</jats:p>', 'DOI': '10.3389/fphar.2022.1011522', 'type': 'journal-article', 'created': {'date-parts': [[2022, 11, 8]], 'date-time': '2022-11-08T07:02:23Z', 'timestamp': 1667890943000}, 'update-policy': 'http://dx.doi.org/10.3389/crossmark-policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'The effect of Nigella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 ' 'patients: A randomized controlled clinical trial', 'prefix': '10.3389', 'volume': '13', 'author': [ {'given': 'Shimaa A.', 'family': 'Said', 'sequence': 'first', 'affiliation': []}, {'given': 'Alsayyed', 'family': 'Abdulbaset', 'sequence': 'additional', 'affiliation': []}, {'given': 'Amal A.', 'family': 'El-Kholy', 'sequence': 'additional', 'affiliation': []}, {'given': 'Osama', 'family': 'Besckales', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nagwa A.', 'family': 'Sabri', 'sequence': 'additional', 'affiliation': []}], 'member': '1965', 'published-online': {'date-parts': [[2022, 11, 8]]}, 'reference': [ { 'key': 'B1', 'doi-asserted-by': 'publisher', 'first-page': '1914', 'DOI': '10.3390/PLANTS11151914', 'article-title': 'Bio-guided isolation of SARS-CoV-2 main protease inhibitors from ' 'medicinal plants: In vitro assay and molecular dynamics', 'volume': '11', 'author': 'Abdallah', 'year': '2022', 'journal-title': 'Plants'}, { 'key': 'B2', 'doi-asserted-by': 'publisher', 'first-page': '441', 'DOI': '10.1007/978-3-030-73234-9_29', 'article-title': 'Resveratrol as a probable multiheaded treatment approach for COVID-19', 'volume': '1328', 'author': 'Ahmadian', 'year': '2021', 'journal-title': 'Adv. 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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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