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Published Clinical Studies
Black Seed Herb

• The in vitro effect of aqueous extract of Nigella sativa seeds on nitric oxide production.(click here to view report)
  
• Neuropharmacological activity of Nigella sativa L. extracts.(Click here to view)
  
• Chemopreventive potential of volatile oil from black cumin (Nigella sativa L.) seeds against rat colon carcinogenesis.(Click here to view)
  
• Nigella sativa (black cumin) ameliorates potassium bromate-induced early events of carcinogenesis: diminution of oxidative stress.(Click here to view)
  
• Delayed apoptosis upon the treatment of Hep-2 cells with black seed.(Click here to view)
  
• Effect of Nigella sativa (N. sativa L.) and oxidative stress on the survival pattern of MCF-7 breast cancer cells.(Click here to view)
  
• Protective effect of Nigella sativa seeds against carbon tetrachloride-induced liver damage.(Click here to view)
  
• Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases.(Click here to view)
  

The in vitro effect of aqueous extract of Nigella sativa seeds on nitric oxide production.

Mahmood MS, Gilani AH, Khwaja A, Rashid A, Ashfaq MK.

Department of Biological and Biomedical Sciences, The Aga Khan University Medical College, Karachi, Pakistan.

The in vitro effect of aqueous extract of Nigella sativa seeds on nitric oxide (NO) production by murine macrophages was studied. Murine peritoneal macrophages were pre-incubated with the extract and then activated with Escherichia coli lipopolysaccharride. NO production was measured after 24 hours by spectrophotometry. The plant extract caused a dose-dependent decrease in NO production. Dialyzed preparation of the extract did not affect NO production. However, the boiled fraction of the extract resulted in a dose-dependent inhibition of NO apparently comparable to that of the whole extract. These results indicate that the aqueous extract of N. sativa seeds exhibits an inhibitory effect on nitric oxide production by murine macrophages and the active component(s) is/are non-protein in nature. In view of the fact that nitric oxide is a pro-inflammatory mediator, this study validates the traditional use of the Nigella sativa seeds for the treatment of rheumatism. Copyright 2003 John Wiley & Sons, Ltd.

PMID: 13680825 [PubMed - indexed for MEDLINE]

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Neuropharmacological activity of Nigella sativa L. extracts.

Al-Naggar TB, Gomez-Serranillos MP, Carretero ME, Villar AM.

Facultad de Farmacia, Universidad Complutense de Madrid, 28040 Madrid, Spain.

Pharmacological studies have been conducted on the aqueous and methanol extracts of defatted Nigella sativa L. seeds to evaluate their effects on the central nervous system (CNS) and on analgesic activity. The observations suggest that the two extracts of Nigella sativa possesses a potent CNS and analgesic activity (depressant action especially in the case of the methanolic extract).

PMID: 12902052 [PubMed - indexed for MEDLINE]

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Chemopreventive potential of volatile oil from black cumin (Nigella sativa L.) seeds against rat colon carcinogenesis.

Salim EI, Fukushima S.

Laboratory of Experimental and Molecular Carcinogenesis, Department of Zoology, Faculty of Science, Tanta University, Tanta 31527-Egypt.

Chemopreventive effects of orally administered Nigella sativa oil on the induction and development of 1,2-dimethylhydrazine-induced aberrant crypt foci (ACF), putative preneoplastic lesions for colon cancer, were investigated in Fischer 344 rats. Starting at 6 wk of age, 45 male rats (groups 1-3) were subcutaneously injected with DMH once a week for 3 wk. Group 1 (15 rats) served as a carcinogen control group without N. sativa administration. Group 2 or 3 (15 rats each) were given the oil in the postinitiation stage or in the initiation stage, respectively. Animals of group 4 (11 rats) were injected with 0.9% saline and received N. sativa oil from the beginning until the termination. At sacrifice, 14 wk after the start, the total numbers of ACF as well as those with at least four crypts were significantly reduced in group 2 (P < 0.01). However, treatment with N. sativa oil in the initiation stage (group 3) did not exhibit significant inhibitory effects except on foci with only one aberrant crypt. Immunohistochemical analysis of 5-bromo-2'.-deoxyuridine labeling in colonic crypts revealed the N. sativa oil to have significant antiproliferative activity in both initiation and postinitiation stages and especially in the latter. Histological examination revealed no pathological changes in the liver, kidneys, spleen, or other organs of rats treated with N. sativa. In addition, biochemical parameters of blood and urine as well as body weight gain were not affected. These findings demonstrate that the volatile oil of N. sativa has the ability to inhibit colon carcinogenesis of rats in the postinitiation stage, with no evident adverse side effects, and that the inhibition may be associated, in part, with suppression of cell proliferation in the colonic mucosa.

PMID: 12881014 [PubMed - in process]

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Nigella sativa (black cumin) ameliorates potassium bromate-induced early events of carcinogenesis: diminution of oxidative stress.

Khan N, Sharma S, Sultana S.

Section of Chemoprevention and Nutrition Toxicology, Department of Medical Elementology and Toxicology, Faculty of Science, Jamia Hamdard, Hamdard University, New Delhi 110 062, India.

Potassium bromate (KBrO3) is a potent nephrotoxic agent. In this paper, we report the chemopreventive effect of Nigella sativa (black cumin) on KBrO3-mediated renal oxidative stress, toxicity and tumor promotion response in rats. KBrO3 (125 mg/kg body weight, intraperitoneally) enhances lipid peroxidation, gamma-glutamyl transpeptidase, hydrogen peroxide and xanthine oxidase with reduction in the activities of renal antioxidant enzymes and renal glutathione content. A marked increase in blood urea nitrogen and serum creatinine has also been observed. KBrO3 treatment also enhances ornithine decarboxylase (ODC) activity and [3H] thymidine incorporation into renal DNA. Prophylaxis of rats orally with Nigella sativa extract (50 mg/kg body weight and 100 mg/kg body weight) resulted in a significant decrease in renal microsomal lipid peroxidation (P < 0.001), gamma-glutamyl transpeptidase (P < 0.001), H2O2 (P < 0.001) and xanthine oxidase (P < 0.05). There was significant recovery of renal glutathione content (P < 0.01) and antioxidant enzymes (P < 0.001). There was also reversal in the enhancement of blood urea nitrogen, serum creatinine, renal ODC activity and DNA synthesis (P < 0.001). Data suggest that Nigella sativa is a potent chemopreventive agent and may suppress KBrO3-mediated renal oxidative stress, toxicity and tumour promotion response in rats.

PMID: 12755470 [PubMed - indexed for MEDLINE]

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Delayed apoptosis upon the treatment of Hep-2 cells with black seed.

Corder C, Benghuzzi H, Tucci M, Cason Z.

University of Mississippi Medical Center, Jackson, MS 39216, USA.

Nigella sativa (Black seed, BS) has been used to promote health and fight disease for centuries. The objectives of this investigation were: (1) to study whether agents such as cortisol and LPS alone or in combination induce cellular (Hep-2, laryngeal carcinoma) damage with time in culture (24, 48, and 72 hours) using apoptosis as a marker, (2) to determine if an immune stimulant such as BS, can protect Hep-2 cells from insult and ultimately thwart the programmed cells death mechanism. A total of 54 Hep-2 cell/tubes (50,000 cells per tube) were divided into six equal groups. Group one served as untreated control, while groups 2-6 were treated with either cortisol (10 ng/ml), LPS (10 micrograms/ml), BS (25 micrograms/ml), or a combination of LPS and cortisol and cortisol plus LPS plus BS, respectively. At the end of each phase the cells were harvested, heat fixed and stained with H&E to evaluate morphological changes. Immunohistochemistry, using antibodies against caspace-3 to evaluate cells undergoing apoptosis was conducted in all groups. The results of this study showed evidence of cells undergoing apoptosis at different magnitudes in all groups. However, the most dramatic change was seen in groups containing cortisol and LPS alone or in combination. This was supported by the fact that there were several adaptive responses observed in all phases. In addition, the exposure of BS to cells pretreated with cortisol and LPS showed evidence of protection against the progressive apoptosis.

PMID: 12724921 [PubMed - indexed for MEDLINE]

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Effect of Nigella sativa (N. sativa L.) and oxidative stress on the survival pattern of MCF-7 breast cancer cells.

Farah IO, Begum RA.

Jackson State University, Jackson, MS 39217, USA.

N. Sativa L., an oriental spice, has long been used as a natural medicine for treatment of many acute as well as chronic conditions. It has been used in the treatment of diabetes, hypertension, and dermatological conditions. There has been very few studies on the effects of N. Sativa as cancer prevention/therapy. Our objective therefore, was to expose MCF-7 breast cancer cells to aqueous and alcohol extracts and in combination with H2O2 as an oxidative stressor. Measurement of cell survival under various concentrations and combinations was conducted using standard cell culture techniques, exposure protocols in 96 well plates and Fluoro-spectrosphotometry. Following cellular growth to 90% confluency, exposure to water (WE) and ethanol (AE) extracts of N. sativa and H2O2 was performed. Toxicity index (LC50) was calculated from percent survival using regression analysis. Results showed that the alcohol extract and its combinations were able to completely inactivate the MCF-7 cells (LC50 ranged from 377.16-573.79 in descending potency for H2O2 + AE, AE and Mix of WE and AE). H2O2 alone effectively inactivated MCF-7 cells (LC50 = 460.94). The least effective combinations in descending potency were WE + H2O2, WE + AE + H2O2, and WE (LC50 were 725.79, 765.94, and 940.5 respectively. Combinations other than AE + H2O2 showed possible interactions, which lead to reduction in their potency. In conclusion, N. Sativa alone or in combination with oxidative stress were found to be effective in vitro in inactivating MCF-7 breast cancer cells, unveiling opportunities for promising results in the field of prevention and treatment of cancer.

PMID: 12724920 [PubMed - indexed for MEDLINE]

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Protective effect of Nigella sativa seeds against carbon tetrachloride-induced liver damage.

Al-Ghamdi MS.

Department of Pharmacology, College of Medicine, King Faisal University, Dammam, Saudi Arabia. mghamdi@Dammam.kfu.edu.sa

It has been reported that Nigella sativa oil possesses hepatoprotective effects in some models of liver toxicity. However, it is N. sativa seeds that are used in the treatment of liver ailments in folk medicine rather than its oil. Therefore, the aim of this study was to investigate the effect of the aqueous suspension of N. sativa on carbon tetrachloride (CCL4)-induced liver damage. Aqueous suspension of the seeds was given orally at two dose levels (250 mg/kg and 500 mg/kg) for five days. CCL4 (250 microl/kg intraperitoneally / day in olive oil) was given to the experimental group on days 4 and 5, while the control group was only treated with the vehicles. Animals treated with CCL4 showed remarkable centrilobular fatty changes and moderate inflammatory infiltrate in the form of neutrophil and mononuclear cells when compared to the controls. This effect was significantly decreased in animals pretreated with N. sativa. Histopathological or biochemical changes were not evident following administration of N. sativa alone. Serum levels of aspartic transaminase (AST), and L-alanine aminotransferase (ALT) were slightly decreased while lactate dehydrogenase (LDH) was significantly increased in animals treated with CCL4 when compared to the control group. LDH was restored to normal but ALT and AST levels were increased in animals pretreated with N. sativa. In conclusion, N. sativa seeds appeared to be safe and possibly protective against CCL4-induced hepatotoxicity. However, further studies may still be needed prior to supporting its use in folk medicine for hepatic diseases.

PMID: 14696675 [PubMed - in process]

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Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases.

Kalus U, Pruss A, Bystron J, Jurecka M, Smekalova A, Lichius JJ, Kiesewetter H.

Humboldt University, Berlin, School of Medicine, Institute for Transfusion Medicine, Charite University Hospital, Berlin, Germany.

Nigella sativa (black seed) is an important medicinal herb. In many Arabian, Asian and African countries, black seed oil is used as a natural remedy for a wide range of diseases, including various allergies. The plant's mechanism of action is still largely unknown. Due to the lack of study data on its efficacy in allergies, four studies on the clinical efficacy of Nigella sativa in allergic diseases are presented. In these studies, a total of 152 patients with allergic diseases (allergic rhinitis, bronchial asthma, atopic eczema) were treated with Nigella sativa oil, given in capsules at a dose of 40 to 80 mg/kg/day. The patients scored the subjective severity of target symptoms using a predefined scale. The following laboratory parameters were investigated: IgE, eosinophil count, endogenous cortisol in plasma and urine, ACTH, triglycerides, total cholesterol, LDL and HDL cholesterol and lymphocyte subpopulations. The score of subjective feeling decreased over the course of treatment with black seed oil in all four studies. A slight decrease in plasma triglycerides and a discrete increase in HDL cholesterol occurred while the lymphocyte subpopulations, endogenous cortisol levels and ACTH release remained unchanged. Black seed oil therefore proved to be an effective adjuvant for the treatment of allergic diseases. Copyright 2003 John Wiley & Sons, Ltd.

PMID: 14669258 [PubMed - in process]

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References

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2. The Review of Natural Products by Facts and Comparisons. St. Louis, MO: Wolters Kluwer Co., 1999.



3. Akhtar MS, et al. Field trial of Saussurea lappa roots against nematodes and Nigella sativa seeds against cestodes in children. JPMA J Pak Med Assoc 1991 Aug;41(8)185-7.



4. Tennekoon KH, Jeevathayaparan S, Kurukulasooriya AP, Karunanayake EH. Possible hepatotoxicity of Nigella sativa seeds and Dregea volubilis leaves. J Ethnopharmacol 1991;31(3):283-9.



5. Keshri G, Singh MM, Lakshmi V, Kamboj VP. Post-coital contraceptive efficacy of the seeds of Black seed in rats. Indian J Physiol Pharmacol 1995;39(1):59-62.



6. Aqel M, Shaheen R. Effects of the volatile oil of Black seed seeds on the uterine smooth muscle of rat and guinea pig. J Ethnopharmacol 1996;52(1):23-6.



7. Nagi MN, Alam K, Badary OA, et al. Thymoquinone protects against carbon tetrachloride hepatotoxicity in mice via an antioxidant mechanism. Biochem Mol Biol Int 1999;47(1):153-9.



8. Chakravarty N. Inhibition of histamine release from mast cells by nigellone. Ann Allergy 1993;70(3):237-42.



9. Worthen DR, Ghosheh OA, Crooks PA. The in vitro anti-tumor activity of some crude and purified components of blackseed, Black seed L. Anticancer Res 1998;18(3A):1527-32.



10. Daba MH, Abdel-Rahman MS. Hepatoprotective activity of thymoquinone in isolated rat hepatocytes. Toxicol Lett 1998;95(1):23-9.



11. Salomi NJ, Nair SC, Jayawardhanan KK, et al. Antitumour principles from Black seed seeds. Cancer Lett 1992;63(1):41-6.



12. Houghton PJ, Zarka R, de las Heras B, Hoult JR. Fixed oil of Black seed and derived thymoquinone inhibit eicosanoid generation in leukocytes and membrane lipid peroxidation. Planta Med 1995;61(1):33-6.



13. Haq A, Abdullatif M, Lobo PI, et al. Black seed: effect on human lymphocytes and polymorphonuclear leukocyte phagocytic activity. Immunopharmacology 1995;30(2):147-55.



14. Badary OA, Al-Shabanah OA, Nagi MN, et al. Inhibition of benzo(a)pyrene-induced forestomach carcinogenesis in mice by thymoquinone. Eur J Cancer Prev 1999;8(5):435-40.



15. Medenica RD. Use of Black seed to increase immune function. U.S. Patent 5,482,711, issued January 9, 1996. Obtained from US Patent and Trademark Ofc on April 12, 2000. www.uspto.gov/patft/index.htm.

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