COVID-19 Herbs: Multicenter Randomized Controlled Trial Shows That Nigella Sativa And Honey Is Able To Treat Moderate To Severe COVID-19 Patients

In the first ever multicenter randomized controlled trial study involving herbs to treat COVID-19, researchers from Pakistan, Canada, Chile and the United States have shown that the herb Nigella Sativa (Fennel Flower or Black Caraway Plant or Kalonji) and honey is able to treat moderate and severe COVID-19 patients.


 
The study findings were published on a preprint server is currently being peer reviewed. https://www.medrxiv.org/content/10.1101/2020.10.30.20217364v2
 
Nigella sativa is an annual flowering plant in the family Ranunculaceae, native to a large region of the eastern Mediterranean, northern Africa, the Indian Subcontinent, and West Asia. N. sativa grows to 20–30 cm tall, with finely divided, linear leaves. It has been used as a medicinal plant in South Asian countries like India, Pakistan, Bangladesh and also in Myanmar and Northern Thailand.
 
It has been shown to exert antiviral effects against a variety of viruses such as Mouse Cytomegalovirus and HCV. https://pubmed.ncbi.nlm.nih.gov/28480371/
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3646144/
 
https://pubmed.ncbi.nlm.nih.gov/10884593/
 
It has also been shown to decrease replication of SARS-CoV in-vitro in cell cultures. https://covid19.elsevierpure.com/zh/publications/the-effects-of-nigella-sativa-ns-anthemis-hyalina-ah-and-citrus-s
 
The herb also has antiviral effects on the HIV virus. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3847425/
 
Molecular docking studies have shown that some of its phytochemicals such as nigelledine, α-hederin and thymoquinone, etc., have high affinity with several SARS-CoV-2 enzymes and proteins. In fact, they exhibit an energy complex score better than that of chloroquine, hydroxychloroquine and favipiravir. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445151/
 
The various phytochemical present in Nigella Sativa has inflammatory, antimicrobial and immunomodulatory properties.
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347483/
 
https://pubmed.ncbi.nlm.nih.gov/16275613/
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3048935/
 
https://www.frontiersin.org/articles/10.3389/fphar.2018.01075/full
 
/www.ncbi.nlm.nih.gov/pmc/articles/PMC4884216/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4884216/
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6406245/
 
https://pubmed.ncbi.nlm.nih.gov/26117430/
 
The herb is also used as one of the key components in the nano-encapulated TMN Complex found in Thailand Medical News therapeutic teas for COVID-19.
https://www.thailandmedical.news/news/new-therapeutic-teas-
 
Honey has anti-viral, anti-microbial, anti-inflammatory and immunemodulatory effects with proven safety profiles.
 
https://iubmb.onlinelibrary.wiley.com/doi/full/10.1002/iub.578
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3188067/
 
https://pubmed.ncbi.nlm.nih.gov/29472785/
 
https://www.sciencedirect.com/science/article/abs/pii/S0188440914001106
 
https://www.transbiomedicine.com/translational-biomedicine/in-vitro-antiviral-activity-of-honey-against-varicella-zoster-virus-vzv-a-translational-medicine-study-for-potential-remedy-for-shingles.php?aid=2493
 
Studies have shown beneficial effects of honey against different viruses including rubella virus, Herpes Simplex virus, Hepatitis virus, and Varicella Zoster virus.https://pubmed.ncbi.nlm.nih.gov/25860226/
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3401066

Silico molecular docking studies:

Silico molecular docking studies have shown that six flavonoid compounds from honey might inhibit SARS-CoV-2 replication by binding to the viral 3-chymotrypsin-like-cysteine protease. https://www.ejmo.org/10.14744/ejmo.2020.36102/
 
Honey has also shown efficacy against several multidrug resistant bacteria, especially in synergism with antibiotics. https://pubmed.ncbi.nlm.nih.gov/28855819/
 
Honey also exhibits immunity-boosting effects mainly via its polyphenolic components, which stimulate both innate and adaptive immune responses. Its use has shown to be beneficial in upper respiratory tract infections.
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424551/
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822819/
 
https://pubmed.ncbi.nlm.nih.gov/32817011/
 
The Nigella sativa with honey combination has been used to treat a variety of diseases.
https://www.msjonline.org/index.php/ijrms/article/view/382
 
https://www.jocms.org/index.php/jcms/article/view/517
 
https://www.jahjournal.org/article.asp?issn=1658-5127;year=2017;volume=8;issue=3;spage=119;epage=122;aulast=Al;type=0
 

Similar pharmacological profiles:

The study team reasoned that since Nigella sativa and honey showed similar pharmacological profiles, the combination could be more effective in attenuating severity of the COVID-19 disease, controlling viral replication and curing COVID-19 patients
 
Typically an ideal COVID-19 treatment would speed up symptomatic recovery, decrease viral load, and expedite viral clearance and reduce mortality.
 
To date no drugs including approved by the U.S. FDA such as remdesivir is able to achieve that .
 
This study however showed that the usage of Nigella sativa with honey resulted in earlier recovery and viral clearance in COVID-19 patients.
 
The research team conducted a randomized, controlled clinical trial to investigate the potential effectiveness of a combination of Nigella sativa and honey in treating COVID-19 patients.
 
The study team performed a multicenter, randomized, controlled trial in patients with COVID-19 of varying severity. Randomized patients received either a combination of 1 gm/kg/day of honey and 80 mg/kg/day of Nigella sativa or placebo for 13 days. Viral clearance, symptoms, alleviation, and 30-day mortality were some of the outcomes.
 
Corresponding author, Dr Sohaib Ashraf  from the Shaikh Zayed Post-Graduate Medical Institute, Lahore- Pakistan  told Thailand Medical news, “The trial results show that the use of Nigella sativa and honey  in COVID-19 patients promotes viral clearance and reduces the severity of the disease.”

Patients with moderate symptoms:

For the study, of the 313 patients, part of the cohort, 210 patients with moderate symptoms and 103 with severe COVID-19 underwent randomization. Among these patients, 107 received Nigella sativa and honey, and 103 moderate cases received a placebo. Fifty severe COVID-19 patients were given Nigella sativa and honey, and 53 severe cases received placebo.
 
Administration of Nigella sativa and honey led to alleviation of symptoms by day 3 in moderate cases and day 7 in severe cases. The study findings showed symptoms alleviation by 3 and 7 days in moderate and severe disease, respectively (Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, 99 P.
 
In moderate patients, the Nigella Sativa and honey group resumed normal activities while control group was unable to resume activities of daily life as evident by the lower median CGS at day 6 (odds ratio: 0.07; 95% CI: 0.03-0.13; P<0.0001). Meanwhile, in severe groups, the HNS 248 cases were discharged whereas the control cases were hospitalized on supplemental oxygen as per 249 median CGS at day 6 (Odds Ratio: 0.03; 95% CI: 0.01-0.09; P><0.0001).
 
For the severe group, the median CGS at day 10 revealed that Nigella sativa and honey  cases resumed normal activities while control patients were still hospitalized requiring oxygen therapy (OR:0.05; 95% CI: 0.02-0.15). Thirty-day mortality was 18.87% in control group and 4% with Nigella sativa and honey therapy (OR: 0.18 95% CI: 0.02-0.92).
 
The study showed superior efficacy of Nigella sativa for COVID-19 in all studied outcomes. About half of the patients in the control groups required double time to become asymptomatic compared with those in the HNS group. In severe cases, the Nigella sativa and honey group had a significantly lower recovery time compared with the control group (6 days versus 13 days,) P<0.0001). In comparison to this, the recovery time reported for remdesivir was 10 days versus 15 days for the control (P<0.001).
 
The study team said, “Anti-diabetic, anti-hypertensive, cardio-protective and broncho-dilatory properties of Nigella sativa and honey make it even more beneficial in diabetic, hypertensive, cardiac and asthmatic patients who have a higher COVID-19 associated mortality.”
 
Nigella sativa and honey could be an affordable, home-based, OTC treatment option for COVID-19 patients.
 
The research findings results show that Nigella sativa and honey helped with symptoms alleviation and viral clearance and reduced mortality in patients with moderate and severe disease.

Nigella sativa and honey:

According to the study team, Nigella sativa and honey can be used as a safe and effective therapy in COVID-19 patients as it promotes quicker recovery and survival. Thus, they concluded that HNS represents an affordable therapeutic option and can be used alone or in combination with other therapies to fight COVID-19.
 
Additional benefits of this potential treatment option are its ‘over the counter’ availability, affordability ie less than US$4 for the entire treatment course, and ease of administration as it can be a home-based remedy. Moreover, Nigella sativa can also be used in combination with other drugs for increased efficacy.
 
The study team says that “A multinational study with larger sample size is required to investigate potential variations in responses to the treatment in COVID-19 patients from different racial and ethnic origins.”
 
A limitation of the study that we at Thailand Medical News note is that the genomic sequencings of SARS-CoV-2 virus strains that were affecting the treated patients were not conducted and identified. This was due to limited genomic testing facilities in Pakistan.
 
We at Thailand Medical News believe that various strains of the SARS-CoV-2 exhibit different characteristics and even reactions to drugs, therapeutics, herbs and phytochemicals and can also develop resistant strains like in the case of Artemisia when used alone. We strongly believe in the approach of multiple combinations drugs, therapeutics, herbs or phytochemicals and also a multiple mechanism approach to target COVID-19, hence our therapeutic teas that have a huge variety of herbs and phytochemicals and also multiple modes of action. https://www.thailandmedical.news/news/new-therapeutic-teas-
 
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