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Kalonji

Scientific Name(s): Nigella sativa L.
Common Name(s): Baraka, Black caraway, Black cumin, Black seed, Charnushka, Fennel flower plant, Fitch, Kalajira, Kalonji, Krishnajirika, Love in the mist, Shonaiz, The blessed seed

Medically reviewed by Drugs.com. Last updated on Jul 3, 2023.

Clinical Overview

Use

There is limited evidence to support Kalonji's use in the management of metabolic syndrome, rheumatoid arthritis, epilepsy, and opioid dependence.

Dosing

Doses of 100 mg of N. sativa extract, 5 mL of oil, and 1.5 to 3 g of powder daily over periods of up to 3 months have been used in metabolic syndrome.

Contraindications

Contraindications have not yet been identified.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. Kalonji is reputedly an emmenagogue and a natural remedy for delayed menses; avoid during pregnancy. The seed has also been used traditionally as a lactogogue.

Interactions

None well documented.

Adverse Reactions

The seed and its constituents are characterized by a low incidence of adverse reactions and toxicity. Allergic dermatitis, mild nausea, and increased appetite have been reported.

Toxicology

Information is limited.

Scientific Family

Botany

N. sativa is an annual plant with terminal, white or grayish-blue flowers between 30 and 60 cm in height and finely divided, thread-like leaves. The toothed seed pod contains the distinctive tiny (1 to 2 mm long), black, 3-sided seeds used for medicinal purposes.1, 2

History

Kalonji has been used for 3,000 years, with historical records of medicinal use dating back 2,000 years. Its use began in the Middle East and spread throughout Europe, Africa, and India. Kalonji seeds were found in the tomb of King Tutankhamun, as the ancient Egyptians believed that medicinal plants such as kalonji played a role in the afterlife. In the first century AD, the Greek physician Dioscorides documented that the seeds were taken for a variety of problems, including headache, toothache, nasal congestion, and intestinal worms. There is a common Islamic belief that kalonji is a remedy for all ailments except aging and death. The seed continues to be used as a traditional medicine in Morocco, Sudan, and many other countries. It is applied either raw or roasted as a spicy/bitter condiment in India and Turkey.1, 3, 4, 5, 6

Chemistry

N. sativa seeds contain fixed oils (26% to 38%), proteins, alkaloids, saponins (melanin), and essential oil (0.4% to 2.5%). The fixed oil is mainly composed of the unsaturated fatty acids linoleic acid and oleic acid. The major component of the volatile essential oil is thymoquinone (28% to 57%). Thymoquinone, dithymoquinone (nigellone), thymohydroquinone, and thymol are considered the main active constituents. At least 4 alkaloids have been isolated: nigellicine and nigellidine (indazoles), and nigellimine and nigellimine N-oxide (isoquinolines). Other constituents include palmitic, glutamic, ascorbic, and stearic acids; arginine; methionine; lysine; glycine; leucine; and phytosterols. Crude fiber, calcium, iron, sodium, and potassium are also present. Nutritional composition of the seeds has been determined as 21% protein, 35% carbohydrate, and 36% fat. Analytical methods, including high-pressure liquid chromatography, thin-layer chromatography, and gas chromatography, have been described in detail.3, 5, 6, 7, 8, 9, 10, 11

Uses and Pharmacology

Anti-inflammatory

Kalonji may exert immunoregulatory effects, but robust data are lacking.21, 68 In vitro studies suggest antieicosanoid and antioxidant activity, as well as inhibition of thromboxane B2 and leukotriene B2 via the inhibition of cyclooxygenase and lipoxygenase.12, 13, 14

Animal data

Research in rodents using various models of analgesia has demonstrated antinociceptive actions of N. sativa oil and anti-inflammatory activity associated with kalonji polyphenols.15, 16, 17 In rats with induced arthritis, oral thymoquinone suppressed both clinical and radiological markers of arthritis.17, 18 The effects of thymoquinone on acetic acid–induced colitis in rats were comparable with sulfasalazine.19

Clinical data

In a small pre- and postrheumatoid arthritis study (N = 40), adjuvant N. sativa oil 500 mg twice daily resulted in improved disease activity scores after 1 month, using the disease activity score (DAS28), European League Against Rheumatism response criteria, and American College of Rheumatology 20 responder index. Further clinical trials are required before a definitive place in therapy can be determined.20 In patients with primary osteoarthritis of the knee, a 12-week oral dose of powdered N. sativa seeds (2 g/day) did not provide a significant improvement in overall pain or function scores (ie, pain, activities of daily living, sport and recreation, quality of life) compared to controls. This double-blind, randomized, placebo-controlled trial (n=110) also recorded use of acetaminophen rescue medication, which was found to be lower in the active treatment group (mean, 11 tablets) compared to placebo (mean, 24 tablets) but was not statistically significant. Increased appetite was the only adverse event that was significantly more common with N. sativa than placebo (19% vs 2.5%, respectively; P=0.02).77

N. sativa was shown to produce significant improvements in symptoms, oxidative stress, relapse rates, and patient satisfaction in 60 patients with moderate to severe psoriasis. Patients received N. sativa (topical 20% w/w plus oral 500 mg 3 times daily), methotrexate (15 mg weekly), or a combination of N. sativa plus methotrexate (topical or oral) for 12 weeks. The percent reduction in Psoriasis Area and Severity Index scores were significantly reduced in all 3 treatment groups (P < 0.0001 for each) at 8 and 12 weeks with the greatest percent reduction occurring with combination therapy (74.6%) at 12 weeks. Patients receiving Nigella therapy or combination therapy experienced significantly improved oxidative stress parameters (P < 0.001 for each therapy) and rates of relapse (33.3% or 27.8%, respectively). In contrast, those receiving methotrexate therapy alone had a significant increase in oxidative stress (P < 0.001) and a relapse rate of 56.3%. Patient satisfaction scores were 80%, 40%, and 15% for Nigella therapy, combination therapy, and methotrexate therapy, respectively. Side effects were not reported in the Nigella group; however, 95% of the methotrexate group reported severe gastric upset that was not present in patients receiving combination therapy.74

Antimicrobial

In vitro studies and screening experiments provide some foundation for the traditional use of N. sativa seeds as an antimicrobial agent, but clinical trials are lacking. Extracts of the seeds have been shown to exert activity against human pathogens, including methicillin-resistant Staphylococcus aureus and Helicobacter pylori.10, 52 Activity against plant fungi and antiplasmodial and antimicrobial activity have also been demonstrated.53, 54, 55, 56, 57, 58, 59

Antioxidant

Both the fixed oil and constituents such as thymoquinone have been shown to exert antioxidant activity, which may be responsible for the protective effects of N. sativa against various toxicities.60, 61, 62, 63, 64, 65, 66, 67 Patients with moderate to severe psoriasis treated with N. sativa (topical 20% w/w plus oral 500 mg 3 times daily) or a combination of topical N. sativa plus methotrexate (15 mg 3 times daily) for 12 weeks were found to have significantly improved oxidative stress parameters (serum malondialdehyde [sMDA]) in contrast to patients who received methotrexate monotherapy who experienced a significant increase in sMDA levels.74

Cancer

In vitro and in vivo studies indicate that the oil and the active constituents of N. sativa seeds possess antitumor effects.21, 22, 23, 24

Animal data

A mixture containing kalonji seeds was protective against diethylnitrosamine-mediated carcinogenic changes in rat livers.24 Kalonji has inhibited tumors in rodents.4, 25 Topical application of kalonji and saffron delayed and reduced papilloma formations in mice.4, 26

Clinical data

The constituents thymoquinone and alpha-hederin have demonstrated cytotoxic actions in human cell lines while sparing normal cells; however, clinical studies are lacking.4, 27, 28

CNS effects

Animal data

A neuroprotective effect was demonstrated in rats with induced ischemic stroke. Grip strength improved in the rats, as did markers of oxidation status, indicating that antioxidant activity was probably involved in the observed effects.29 In another study in rodents, N. sativa oil failed to prevent pilocarpine-induced epilepsy.30

Clinical data

A 12-week, single-blind clinical trial evaluated the effect of N. sativa 500 mg 3 times daily as an adjunctive therapy in the management of opioid dependence in 35 patients. Outcome measures were self-reported reductions in opioid withdrawal symptoms. Further randomized, double-blind trials are required to validate these findings.31 A 4-week pilot, double-blind study in 22 children with refractory seizures found a decrease in the frequency of seizures for thymoquinone 1 mg/kg compared with placebo. Reported adverse events were limited mainly to somnolence and nausea.32

Drug-induced hepatotoxicity

The addition of N. sativa oil (80 mg/kg/day in 3 divided doses) for 1 week after each methotrexate dose administered to newly diagnosed children with acute lymphocytic leukemia was shown to significantly improve prognosis (complete remission, relapse, death) (P = 0.029). Additionally, children receiving Nigella add-on therapy experienced an insignificant increase in methotrexate-induced hepatotoxicity compared with a significant increase experienced by children receiving placebo add-on.75

Metabolic syndrome

Animal data

Studies in rodents have shown markers of diabetes to be improved, and researchers have attempted to elucidate the mechanism of action.33, 34, 35, 36, 37 Limited studies in hypercholesterolemic rabbits have demonstrated positive effects on the lipid profile and reduced plaque formation.38 Studies on hypertension in laboratory animals are generally lacking.39

Clinical data

Specific clinical trials among diabetic and hypertensive populations are limited and some lack robust methodology (eg, too few participants, high drop-out rates, details of randomization not published). However, kalonji powder and oil have both been used to evaluate the plant's effects on lipid profile, blood pressure, and waist circumference with some success. Doses of 100 mg of N. sativa extract, 5 mL of oil, and 2 to 3 g of powder daily over periods of up to 3 months were used.40, 41, 42, 43 The TAK-MetS trial, a double-blind, randomized controlled trial comparing the efficacy of powdered black seeds (kalongi) and turmeric as mono- and combination therapy in Pakistani males with metabolic syndrome reported significant improvements after 8 weeks in triglycerides, cholesterol, fasting blood glucose (FBG), and LDL- and HDL-cholesterol with 1.5 g/day of black seeds compared to placebo, with only cholesterol and triglycerides significantly improved compared to baseline. Combination therapy (900 mg/day black seeds +1.5 g/day turmeric) resulted in significant improvements in percent body fat, all lipid parameters, FBG, and C-reactive protein compared to placebo, and in hip circumference, % body fat, weight, triglycerides, and C-reactive protein compared to black seeds alone. At 8 weeks, the placebo group exhibited significant improvement from baseline in body mass index and percent body fat. Increased nausea was reported at 4 weeks in 1 patient receiving black seeds with only the additional report of excessive weakness plus weight reduction on combination therapy leading to withdrawal of one patient at 6 weeks.76

In 30 healthy males, a double-blind, randomized, placebo-controlled pilot study documented no effect of orally administered 1 g/day N. sativa powder on fasting glucose, serum insulin, glucose-induced insulin secretion or insulin sensitivity. Likewise, no differences were found between groups for any of the lipid parameters.78

Respiratory effects

Animal data

In vitro studies suggest that low concentrations of nigellone inhibit the release of histamine from mast cells and neutrophil elastase activity.44, 45 Effects of the volatile oil of kalonji on the respiratory system have been studied in rodents. Inhibition of 5-lipoxygenase (the main enzyme in leukotriene biosynthesis) has been demonstrated in animal models.46, 47 An antioxidant effect is possibly responsible for the observed reduction in induced hypoxic injury in rats.48

Clinical data

Decreased immunoglobulin E and eosinophil counts have been demonstrated in patients with allergic rhinitis and asthma administered N. sativa oil.49 Anticholinergic and bronchodilatory effects and inhibition of histamine release have also been demonstrated in clinical studies. Kalonji oil has been used at dosages of 40 to 80 mg/kg/day as adjunctive therapy in rhinitis, allergy, and eczema; however, robust clinical evidence is lacking.5, 49 Small studies have evaluated the bronchodilatory effects of kalonji versus theophylline in persons with asthma and in persons with decreased pulmonary function due to chemical injury.50, 51

Dosing

Epilepsy

Thymoquinone 1 mg/kg over 4 weeks has been used in children with refractory seizures.32

Metabolic syndrome

Doses of 100 mg of N. sativa extract, 5 mL of oil, and 2 to 3 g of powder daily over periods of up to 3 months were used.40, 41, 42, 43

Pregnancy / Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. Kalonji is reputedly an emmenagogue and a natural remedy for delayed menses; avoid during pregnancy.69 The seed has also been used traditionally as a lactogogue.10, 69 Limited studies in the 1990s suggested that N. sativa oil might act as a contraceptive.31, 70

Interactions

None well documented.

Adverse Reactions

The seed extract and its constituents are characterized by a low degree of toxicity or adverse reactions.7 Case reports of allergic contact dermatitis from topical use of the oil exist.71, 72, 73 Reported adverse events from clinical studies include somnolence, nausea, and increased appetite.32, 76, 77

Toxicology

Few studies have evaluated the toxicity of N. sativa seeds. The seeds contain melanthin, which is reported to be toxic in large doses, as well as the potentially paralytic nigelline. In rabbits, acute doses of oral seed powder 28 g/kg were not toxic. The median lethal dose (LD50) of the oil is estimated to be 28.8 mL/kg in rats, whereas the LD50 of thymoquinone remains disputed.4

References

Disclaimer

This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

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