Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Trial
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SUBMITTER: Koshak A
PROVIDER: S-EPMC8696021 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo investigate the potential efficacy of Nigella sativa (NS) oil supplementation on the outcomes of patients with mild Coronavirus Disease 2019 (COVID-19).Trial designProspective, two-arm, parallel-group, randomised (1:1 allocation ratio), open-label, controlled, exploratory phase II clinical trial of oral NS oil in patients with mild COVID-19.ParticipantsInclusion Criteria: - Patients with mild COVID19 (defined as upper respiratory tract infection symptoms in the absence of clinical or radiological signs of pneumonia). - Adult (18 - 65 years old). - Written informed consent by the patient (or legally authorized representative) prior to initiation of any study procedures. - All patients should understand and agree to comply with planned study procedures. - Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) from throat swab.Exclusion criteria- Patients with pneumonia or severe illness requiring admission to intensive care unit. - Severe chronic kidney disease (i.e. estimated glomerular filtration rate [eGFR] < 30 mL / min ) or end stage renal disease requiring dialysis - Severe chronic liver disease (Alanine transaminase [AlT] or Aspartate transaminase [AST] > 5 times the upper limit of normal). - Pregnancy or breast feeding. - Anticipated transfer within 72 hours to another hospital that is not a study site. - Allergy to the study medication The trial is currently conducted on patients recruited from King Abdulaziz University Hospital, Jeddah, Saudi Arabia.Intervention and comparatorIntervention group: Nigella sativa oil (MARNYS® Cuminmar) 500 mg softgel capsules, one capsule orally twice daily for 10 days plus standard of care treatment (antipyretic, antitussive). Comparator group: standard of care treatment.Main outcomesProportion of patients who clinically recovered (defined as 3 days of no symptoms) within 14 days after randomisation.RandomisationPatients will be randomly assigned to treatment or control groups in a 1:1 ratio using a computer-generated randomization scheme (Random permuted blocks of 10) developed using the web-based program: http://www.randomization.com .Blinding (masking)No blinding.Numbers to be randomised (sample size)Up to 200 eligible patients will be randomly assigned to either treatment or control groups.Trial statusProtocol version 1, as of July 14, 2020. Recruitment was started on May 21, 2020. The intended completion date is December 31, 2020.Trial registrationClinicalTrials.gov Identifier: NCT04401202 . Date of trial registration: May 26, 2020.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.
| S-EPMC7414256 | biostudies-literature
Project description:BackgroundEffective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19.MethodsAll adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202).ResultsA total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001.ConclusionsNSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies.
| S-EPMC8364675 | biostudies-literature
Project description:The present systematic review and meta-analysis aimed to investigate the effects of Nigella sativa (N. sativa) supplementation on liver enzymes levels including aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Relevant studies, published from inception up to January 2020, were searched through PubMed, Scopus and Google Scholar conducted on randomized controlled trials (RCTs) investigating the effect of N. sativa on serum AST and ALT levels. Meta-analysis was applied using a random-effects model. Eight studies met inclusion criteria (n=281 in the N. sativa and n = 279 in placebo group). This meta-analysis showed that N. sativa supplementation significantly reduced AST level (weighted mean difference [WMD], -8.11 IU/L; 95% confidence interval [CI], -13.6, -2.53; p = 0.004) with significant heterogeneity (I-squared, 95.9%; p < 0.001) while the decrease in ALT level was not statistically significant (WMD, -7.26 IU/L; 95% CI, -15.4, 0.04; p = 0.051) with significant heterogeneity (I-squared, 97.8%; p < 0.001). This meta-analysis suggests that N. sativa supplementation may improve AST levels and ALT levels, however more RCTs with larger sample size are needed to found effects of N. sativa on liver enzymes in patients with non-alcoholic fatty liver disease.
| S-EPMC7850820 | biostudies-literature
Project description:COVID-19 is associated with mitochondrial dysfunction and metabolic abnormalities, including the deficiencies in nicotinamide adenine dinucleotide (NAD+ ) and glutathione metabolism. Here it is investigated if administration of a mixture of combined metabolic activators (CMAs) consisting of glutathione and NAD+ precursors can restore metabolic function and thus aid the recovery of COVID-19 patients. CMAs include l-serine, N-acetyl-l-cysteine, nicotinamide riboside, and l-carnitine tartrate, salt form of l-carnitine. Placebo-controlled, open-label phase 2 study and double-blinded phase 3 clinical trials are conducted to investigate the time of symptom-free recovery on ambulatory patients using CMAs. The results of both studies show that the time to complete recovery is significantly shorter in the CMA group (6.6 vs 9.3 d) in phase 2 and (5.7 vs 9.2 d) in phase 3 trials compared to placebo group. A comprehensive analysis of the plasma metabolome and proteome reveals major metabolic changes. Plasma levels of proteins and metabolites associated with inflammation and antioxidant metabolism are significantly improved in patients treated with CMAs as compared to placebo. The results show that treating patients infected with COVID-19 with CMAs lead to a more rapid symptom-free recovery, suggesting a role for such a therapeutic regime in the treatment of infections leading to respiratory problems.
| S-EPMC8420376 | biostudies-literature
Project description:ObjectiveNigella sativa (N. sativa) from the family Ranunculaceae has medicinal properties. Previous studies have reported promising findings showing that N. sativa may benefit cardiometabolic health; however, current evidence on its cardiometabolic effects on those with prediabetes and type 2 diabetes mellitus (T2DM) is still unclear. Hence, we conducted a systematic review and meta-analysis to assess the efficacy of N. sativa on cardiometabolic parameters in population with prediabetes and T2DM.MethodsPubMed/Medline, ISI Web of Science, Scopus, and Cochrane library were systematically searched up to June 20, 2022. Meta-analyses using random-effects models were used.ResultsEleven randomized controlled trials (RCTs) were included in the meta-analysis. N. sativa intervention resulted in significant changes in fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), c-reactive protein (CRP), and malondialdehyde (MDA), without overall changes in glucose levels after oral glucose tolerance test (OGTT), fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), triglyceride, high-density lipoprotein cholesterol (HDL-C), and body mass index (BMI) when compared with the control group. In subgroup analyses, N. sativa supplementation enhanced serum levels of HDL-C in subjects with baseline HDL-C lower than 40 mg/dL. Furthermore, HOMA-IR and BMI values decreased in the N. sativa-supplemented group compared with the control group, when the length of follow-up was more than 8 weeks and the dose was more than 1 g/day for N. sativa supplementation, respectively.ConclusionOur findings indicate that N. sativa supplementation may effectively improve cardiometabolic profiles in individuals with prediabetes and T2DM.
| S-EPMC9403837 | biostudies-literature
Project description:BackgroundThis study aimed to evaluate whether calcitriol supplementation enhances CD4+ T cell count and prognosis in patients with tuberculosis and low 25(OH)D levels.MethodsThis randomized controlled clinical trial enrolled treatment-naïve patients with tuberculosis admitted to Zigong First People's Hospital (June 2016 to April 2017). The patients were grouped as the serum 25(OH)D ≥ 75 nmol/L (Normal-25(OH)D) and 25(OH)D < 75 nmol/L (Low-25(OH)D) groups. The Low-Vit-D group was randomized to the Low-25(OH)D and Low-25(OH)D-Calcitriol groups. All patients were treated with the 2HRZE/4HR regimen. The patients in the Low-25(OH)D-Calcitriol group received calcitriol 0.25 µg bid. The main endpoints were CD4+ T cell count during treatment, time to sputum culture conversion, time to 50% lesion absorption, and a 6-month cure rate.ResultsThis study included 30 patients in each group. Baseline 25-(OH) D levels and CD4+ T cell counts were higher in the Normal-25(OH)D group than in the Low-25(OH)D and Low-25(OH)D-Calcitriol groups (25(OH)D: 79.3 ± 3.4 vs. 37.8 ± 13.4 vs. 11.9 nmol/L, P < 0.05; 671 ± 287 vs. 200 ± 110 vs. 194 ± 119 cell/µL, P < 0.05). 25-(OH) D levels and CD4+ T cell counts increased in the Low-25(OH)D-Calcitriol group during treatment to reach higher levels than in the Low-25(OH)D group at 1, 4, 8, and 24 weeks (all P < 0.05). Compared with the Low-25(OH)D group, the Low-25(OH)D-Calcitriol group showed shorter time to sputum culture conversion (3.2 ± 1.4 vs. 5.9 ± 2.5 days, P < 0.001) and time to 50% lesion absorption (7.4 ± 1.5 vs. 10.9 ± 4.0 days, P = 0.014) and similar to those in the Normal-25(OH)D group (3.1 ± 1.2 and 7.3 ± 1.5 days, respectively. The cure rate was 86.7% in the Low-25(OH)D group and 96.7% in the two other groups.ConclusionsCalcitriol supplementation can elevate CD4+ T cell levels, shorten the time to sputum culture conversion, and accelerate lesion absorption in patients with tuberculosis and 25(OH)D deficiency. Trial registration The study is registered at the Chinese Clinical Trial Registry (ChiCTR2000039832).
| S-EPMC9074353 | biostudies-literature
Project description:Coronavirus disease-19 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). Currently, the management of patients with COVID-19 depends mainly on repurposed drugs which include chloroquine, hydroxychloroquine, lopinavir/ritonavir, ribavirin, remdesivir, favipiravir, umifenovir, interferon-?, interferon-? and others. In this review, the potential of Nigella sativa (black cumin seeds) to treat the patients with COVID-19 analyzed, as it has shown to possess antiviral, antioxidant, anti-inflammatory, anticoagulant, immunomodulatory, bronchodilatory, antihistaminic, antitussive, antipyretic and analgesic activities. PubMed, Google Scholar, Science Direct, Directory of open access journals (DOAJ) and reference lists were searched to identify articles associated with antiviral and other properties of N.sativa related to the signs and symptoms of COVID-19. Various randomized controlled trials, pilot studies, case reports and in vitro and in vivo studies confirmed that N.sativa has antiviral, antioxidant, anti-inflammatory, immunomodulatory, bronchodilatory, antihistaminic, antitussive activities related to causative oraganism and signs and symptoms of COVID-19. N. sativa could be used as an adjuvant therapy along with repurposed conventional drugs to manage the patients with COVID-19.
| S-EPMC7338708 | biostudies-literature
Project description:This experiment aimed to investigate the effect of dietary Nigella sativa on the cell-mediated immune response. Eighteen male Wistar rats were divided equally into a control group and treated groups that received black seeds at rates of 30 and 50 g/kg in the diet (Sa30 and Sa50 groups, respectively, for 30 days. The weight gain, feed intake, feed conversion ratio (FCR), and cell-mediated immune response were monitored after the injection of 0.1 mL of 10% phytohemagglutinin (PHA). The intumesce index, serum total antioxidant capacity (TAC), catalase (CAT), interleukin-12 (IL-12), gamma interferon (γ-IF) and tumor necrosis factor alpha (TNF-α) were determined. Histopathological examination and an immunohistochemistry analysis of splenic caspase-3 and CD8 were performed. Nigella sativa significantly improved the weight gain and FCR. Intumesce index of Sa50 group was significantly increased. Nigella sativa significantly increased TAC, CAT, IL-12, γ-IF and TNF-α. A histological examination of PHA-stimulated foot pads showed increased leukocyte infiltration and edema in a dose-dependent pattern. Splenic caspase-3 and CD8 showed significant decreases and increases, respectively, in the Sa30 and Sa50 groups. The results indicate that Nigella sativa seeds exhibit immunostimulatory function through their antioxidant potential, induction of cytokine production, promotion of CD8 expression and reduction of splenic apoptosis.
| S-EPMC8024296 | biostudies-literature
Project description:Background and objectivesThe kidney is probably the most crucial target of microvascular damage in diabetes, which can ultimately eventuate end-stage renal disease (ESRD). Hemodialysis is the most usual way of renal replacement therapy in ESRD. Patients receiving hemodialysis are susceptible to many complications like hyperglycemia, inflammation, depression, anxiety, and poor quality of life. So, they are constrained to consume many drugs. Medicinal herbs are used in different cultures as a reliable source of natural remedies. This study aims to determine the efficacy of Nigella sativa (NS) oil supplementation on blood glucose, kidney function tests, inflammation, oxidative stress, quality of life, and depression in hemodialysis patients.Methods and analysisThis double-blind, randomized controlled trial will enroll 46 patients with diabetes mellitus who give hemodialysis thrice a week. Patients who have an inflammatory or infectious disease and who are receiving nonsteroidal anti-inflammatory drugs will be excluded. Patients will be randomized to the treatment and control group, which will be recommended using two soft gels of NS and paraffin oil, respectively. Laboratory tests will be assessed at baseline and end of the study, including fasting blood sugar, glycated albumin, insulin, creatinine, blood urea nitrogen, urea, uric acid, superoxide dismutase, malondialdehyde, total antioxidant capacity, high sensitive C reactive protein, and 24-h urine volume. Also, the kidney disease and quality of life and hospital anxiety and depression scale questionnaires will be evaluated.DiscussionPrevious studies have reported a positive effect of Nigella sativa supplementation in chronic kidney disease, but there is no evidence that this plant is safe in hemodialysis patients. The results of this study can be helpful in better control of blood sugar and kidney function and reduce complications in diabetic hemodialysis patients.Trial registrationIranian Registry of Clinical Trials . Registered on 31 May 2020.
| S-EPMC8815251 | biostudies-literature
Project description:The aim of this systematic review was to identify randomized controlled trials that looked at the effects of Nigella sativa in any form on different skin diseases. Up to March 2022, the online databases of Scopus, Web of Science, PubMed, Embase, Google Scholar, and Cochrane trials were searched. This study included 14 records of people who had experienced different types of skin disease including atopic dermatitis, vulgaris, arsenical keratosis, psoriasis, vitiligo, acute cutaneous leishmaniasis, warts, eczema, and acne. The mean SD age of the patients was 28.86 (4.49); [range: 18.3-51.4], with females accounting for 69% (506 out of 732) of the total. The follow-up mean SD was 8.16 (1.3) (ranged: 4 days to 24 weeks). The odds ratio (OR) was found to be 4.59 in a meta-analysis (95% CI: 2.02, 10.39). Whereas the null hypothesis in this systematic review was that lotion had no impact, OR 4.59 indicated that lotion could be effective. The efficacy of N. sativa essential oil and extract has been demonstrated in most clinical studies. However, more research is needed to completely evaluate and validate the efficacy or inadequacy of therapy with N. sativa, although it appears that it can be used as an alternative treatment to help people cope with skin problems.
| S-EPMC9744621 | biostudies-literature