Black Seed for Coronavirus Treatment

Black seed is cure for every disease except death.
Hadiths.

 

Highlights

Nigella sativa, or Prophetic medicine, does an excellent job of treating and preventing COVID-19 infection.

Black cumin oil and seeds will speed up the cure of the SARS-CoV-2 coronavirus, prevent the development of severe COVID-19, and even help not to die from this infection. Black cumin, when prescribed for prophylactic purposes, will prevent symptomatic COVID-19 from developing.

Just to be clear: A number of clinical trials have confirmed that black seed does help with COVID-19. Another question is how reliable these studies are. Again, there is no consensus on the pharmaceutical purity of black cumin seeds and oil.

Black seed is especially in demand in the current environment when there are essentially no widely available drugs that are unconditionally effective against SARS-CoV-2, and the population is in no hurry to be vaccinated en masse.

 

Black Seed in Coronavirus: Mechanism of Action

The limited range of drugs effective against COVID-19 infection is forcing the pharmaceutical industry to continue searching for new drugs that can adequately address SARS-CoV-2 coronavirus and the damage it causes.

Therefore, additional herbal preparations containing many biologically active molecules are being considered for the treatment of coronavirus infection. In particular, black cumin (Nigella sativa, black seed, kalonji), also known as Prophetic medicine, is proposed as a potential phytopreparation due to several pharmacological characteristics such as anti-inflammatory, antiviral, and immunomodulatory properties, especially required in the COVID-19 pandemic. [1] [2]

The black seed, a popular spice with high medicinal value, contains several active compounds, including thymoquinone. [3] The safety profile of thymoquinone has been documented in many clinical trials, including asthma therapy trials. [4] A systematic review of randomized clinical trials (RCTs) using the black seed found no serious adverse effects on hepatic or renal function. [5] Several preclinical and clinical studies have confirmed the antiviral activity of black cumin against a number of viruses, including influenza, hepatitis C and HIV viruses, and cytomegalovirus. [6] [7] [8] [9] [10] [11] [12] [13] [14] In vitro study showed that the SARS-CoV-1 load was reduced with the black seed. [8]

Several compounds in black cumin have demonstrated potential inhibition of SARS-CoV-2 replication in silico models. [15]

Thus, nigellidine in the black seed, by binding to the active/catalytic sites of nonstructural protein 3 (Nsp3) of coronavirus and inflammatory/apoptotic signaling molecules of the host organism, such as Fas receptor (FasR) and tumor necrosis factor receptors 1 and 2 (TNFR1/TNFR2), suppresses SARS-CoV-2 replication/transcription and inhibits cell death mediating tissue damage. [16]

Dithymoquinone in the black seed binds to the 3C-like protease (3CL^pro) required by coronavirus for replication, and nonstructural protein 15 (Nsp15), responsible for suppressing innate immunity through macrophage infection and evasion of the immune system, among other things. [17]

α-hederin, dithymoquinone, nigellicine, and nigellidine in the black seed exhibit high binding affinity against RNA-dependent RNA polymerase (RdRp) of coronavirus, critical for its trouble-free replication. [18]

The inhibitory activity of nigellamine A2 and A3 (NA2/NA3) in black seed against 3CL^pro has been shown. [19]

It was found that caryophyllene oxide in the black seed is characterized by high-affinity binding to 3CL^pro and RdRp, as well as nonstructural proteins 3 and 9 (Nsp3/Nsp9). Meanwhile, α-bergamotene exhibits affinity for the replicase polyprotein 1a (RP1A) and β-bisabolene exhibits affinity for angiotensin-converting enzyme 2 (ACE2). [20]

The immune system involves a complex cellular system that protects against unwanted pathogen invasions. However, proper functioning requires coordinated action between its elements. [21] Several studies have shown that black cumin exhibits immunostimulatory effects through the induction of multiple cellular mediators and immune responses aimed at destroying infections. [22] [23] [24] [25] In contrast, in studies on inflammatory diseases, black cumin has been shown to have anti-inflammatory and immunomodulatory activity by reducing pro-inflammatory mediators. [25] Analgesic, antipyretic, and bronchodilator properties of black cumin have been reported. [26] [27] [28].

 

Black Seed Oil vs. COVID-19: Healing Effect of Nigella Sativa

In early November 2021, Novatek Pharmaceuticals has reported the success of a clinical trial of the oral drug TQ Formula among outpatients with COVID-19.

TQ Formula is a proprietary formulation of black seed oil (Nigella sativa) in an enteric-coated tablet with a calibrated 2% concentration of thymoquinone. Laboratory studies have found that TQ Formula blocks the entry of SARS-CoV-2 variants into cells by inhibiting angiotensin-converting enzyme 2 (ACE2).

The U.S. Food and Drug Administration (FDA) will meet with Novatek to determine for sure whether TQ Formula should be allowed to treat non-hospitalized patients with COVID-19.

The BOSS-COVID-19 (NCT04914377) phase 2 (randomized, double-blind, placebo-controlled, multicenter) clinical trial enrolled non-hospitalized adult patients (n=60) from the United States with a laboratory-confirmed diagnosis of COVID-19 presenting with mild to moderate severity.

Participants were given placebo or 3 g of TQ Formula (3 capsules of 500 mg twice daily) — for 14 days with standard treatment.

Administration of TQ Formula versus placebo resulted in a significantly faster reduction in overall symptom burden (p=0.006), defined as duration and severity of COVID-19 symptoms from day 1 to day 14, according to the Flu-PRO Plus patient questionnaire for influenza and influenza-like illnesses, modified for COVID-19 features.

Subjects who received the TQ Formula showed a significant increase in the cytotoxic T-lymphocyte CD8⁺ population (p=0.038) and T-helper CD4⁺ cells (p=0.025), as well as a trend toward an accelerated decrease in viral load (p=0.18). This suggests that black seed oil supports immune system recovery in coronavirus.

The safety profile of TQ Formula was favorable: the experimental treatment was very well tolerated and no serious adverse events were observed.

 

Black Seed Oil Speeds Up Recovery From Coronavirus

In mid-August 2021, the results of the NCT04401202 phase 2 clinical trial (randomized, open-label, placebo-controlled) involving adult patients (n=183) from Saudi Arabia with a laboratory-confirmed diagnosis of COVID-19 infection of mild severity became available.

Subjects on standard therapy additionally received placebo or black seed oil — for 10 days. The experimental treatment was Marnys Cuminmar capsules (with 1.28% thymoquinone) administered at 500 mg twice daily.

Clinical recovery, defined as the absence of COVID-19 symptoms within 14 days of randomization, was reported for 62% (n=54/87) of patients in the black seed oil group — versus 36% (n=31/86) of patients in the control group (p=0.001).

Administration of the black seed oil resulted in a reduction in the time it took to recover: an average of 10.7±3.2 days — vs. 12.3±2.8 days (p=0.001).

So, adding the black seed oil to standard COVID-19 treatment reduced the risk of hospitalization by 75% — risk ratio (RR) 0.25 (p=0.37), and also reduced the risk of no recovery by 43% — RR 0.57 (p<0.001).

 

Black Seeds for COVID-19 Prevention

In January 2021, the preventive value of black cumin seeds in the task of preventing the development of COVID-19 infection in individuals at risk was demonstrated.

A clinical trial (non-randomized, open-label) conducted in Iraq invited adult volunteers (n=376) who were stratified according to their risk level for infection with SARS-CoV-2 coronavirus.

Risk levels were stratified as follows: high risk — working in the healthcare system or living with an infected family member, intermediate risk — close contact with the population (school, high-density workplaces, or high volume retail sales), and low risk — minimal occupational contact with the population or employees.

One group of participants was prescribed black cumin seeds (40 mg/kg) daily before breakfast; the second group received none.

Administration of black cumin seeds was found to reduce the risk of symptomatic COVID-19 by 62% — risk ratio (RR) 0.38 (p<0.001). In the high-risk group, however, black seeds had no beneficial protective effect, whereas in the intermediate and low-risk groups it provided a 17.6% and 0.0% reduction in risk of coronavirus infection.

 

Black Seeds Prevent Severe COVID-19

In January 2021, the results of a clinical trial (randomized, open-label, placebo-controlled) conducted in Iraq that enrolled patients (n=419) with laboratory-confirmed COVID-19 infection were published.

Participants were given either standard therapy or the same therapy with the addition of black cumin seeds (40 mg/kg) once daily for 14 days.

The experimental treatment resulted in a 96% reduction in the risk of death — risk ratio (RR) 0.04 (p=0.001), and a 93% reduction in the risk of severe COVID-19 — RR 0.07 (p<0.001).

 

Black Seeds for Coronavirus Help Not to Die

In early November 2020, the results of the NCT04347382 phase 3 clinical trial (randomized, double-blind, placebo-controlled, multicenter) inviting adult patients (n=313) from Pakistan with a laboratory-confirmed diagnosis of moderately-severe COVID-19 infection were summarized.

Exclusion criteria included: multiple organ failure, need for oxygen support, chronic diseases (except diabetes mellitus and hypertension).

Subjects who received standard COVID-19 treatment were additionally treated with placebo or honey (1 g/kg/day) with black cumin seeds in capsules (80 mg/kg/day) divided into two to three doses — for a maximum of 13 days.

Experimental treatment resulted in an acceleration of SARS-CoV-2 clearance by 4 days. Thus, in the subgroup of patients with moderate severity of COVID-19 course this occurred in 6 days — versus 10 days in the control group (hazard ratio [HR] 5.53 [95% CI: 3.76–8.14]; p<0.0001). In the subgroup of patients with severe COVID-19, it occurred in 8.5 days — vs. 12 days in the placebo group (HR 4.32 [95% CI: 2.62–7.13]; p<0.0001).

Adding honey and black cumin seeds to standard covid treatment accelerated relief of symptoms by approximately half: in 4 days versus 7 days in the subgroup of subjects with a moderate course of infection (HR 6.11 [95% CI: 4.23–8.84]; p<0.0001) and in 6 days versus 13 days in the subgroup with a severe course (HR 4.04 [95% CI: 2.46–6.64]; p<0.0001).

On day 6 of treatment, according to the 7-point clinical assessment scale, administration of honey with black cumin seeds provided a return to normal activity among 64% of patients in the moderate COVID-19 subgroup vs. 11% (odds ratio [OR] 0.07 [95% CI: 0.03–0.13]; p<0.0001), and hospital discharge for 50% of patients in the severe COVID-19 subgroup vs. 3% (OR 0.03 [95% CI: 0.01–0.09]; p<0.0001).

During the 30-day follow-up period for severe COVID-19 cases, mortality in the experimental treatment group was 4 times lower relative to the placebo group: 4% of patients died — vs. 19% (OR 0.18 [95% CI: 0.02–0.92]; p=0.029).

Thus, the addition of honey and black cumin seeds to standard COVID-19 therapy resulted in an 82% reduction in the risk of death (without regard to the severity of disease) — risk ratio (RR) 0.18 (p=0.01). Meanwhile, among patients with moderate COVID-19, the risk of death was reduced by 67% (RR 0.33; p=0.49) and in severe COVID-19 by 79% (RR 0.21; p=0.03).

Experimental treatment provided an 84% (RR 0.16; p<0.001) reduction in the risk of no recovery for moderate disease and 75% (RR 0.25; p<0.001) for severe disease, and an 82% (RR 0.18; p<0.001) reduction in the risk of no virological cure for moderate disease and 77% (RR 0.23; p<0.001) for severe disease.