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Comments

provided by eFloras
The aromatic fruits (cumin) are used as a flavoring, to aid digestion, and are of reputed medicinal value. This species is widely cultivated in favorable climates outside its presumed native range. It readily escapes and becomes more or less naturalized locally in many areas.
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Flora of China Vol. 14: 75 in eFloras.org, Missouri Botanical Garden. Accessed Nov 12, 2008.
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Wu Zhengyi, Peter H. Raven & Hong Deyuan
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Comments

provided by eFloras
A species possibly indigenous to the upper Nile region in Egypt and cultivat¬ed in many places in the Mediterranean region and elsewhere. The fruit is used medicinally for digestive ailments and is also used as a spice
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Flora of Pakistan Vol. 0 in eFloras.org, Missouri Botanical Garden. Accessed Nov 12, 2008.
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S. I. Ali & M. Qaiser
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Description

provided by eFloras
Plants 10–30(–50) cm. Basal petioles 1–2 cm, sheaths lanceolate, margins white and membranous; blade 3–8 × 2–7 cm; ultimate divisions long-filiform, 15–60 × 0.4–0.7 mm. Umbels many, 2–3 cm across; peduncles 3–10 cm; bracts 2–6(–8), linear or linear-lanceolate, 10–50 × 0.5–1.2 mm, unequal, entire or apex 2–3-fid, usually longer than the rays, margins membranous; rays (1–)3–6, 3–20 mm, rather stout, very unequal; bracteoles 3–5, similar to bracts, 4–10 × 0.3–0.6 mm, very unequal, sometimes reflexed; umbellules 3–8-flowered; pedicels 3–6 mm, stout, very unequal. Calyx teeth 0.5–2 mm, longer than the styles. Petals ca. 1.4 × 1 mm. Fruit 5–7 × 1.6–2.8 mm; primary ribs short setulose, secondary ribs densely stellate setulose. Fl. and fr. Feb–Jun(–Sep).
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Missouri Botanical Garden, 4344 Shaw Boulevard, St. Louis, MO, 63110 USA
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Flora of China Vol. 14: 75 in eFloras.org, Missouri Botanical Garden. Accessed Nov 12, 2008.
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Flora of China @ eFloras.org
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Wu Zhengyi, Peter H. Raven & Hong Deyuan
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Description

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Plants slender, 15-30 cm tall, branched. Leaves much divided into filiform segments. Involucre of 5-6 linear, entire or ternate bracts with linear segments. Rays 3-6, 5 mm to 1 cm long. Involucel of long linear, white margined bractlets, 5-10 mm long. Calyx teeth prominent, acute, persistent. Petals rose coloured, unequal. Fruit oblong, 5-6 mm long, setulose; stylopodium conical; styles short, erect; vittae solitary under the secondary ridges; commissure 2-vittate
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Missouri Botanical Garden, 4344 Shaw Boulevard, St. Louis, MO, 63110 USA
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Flora of Pakistan Vol. 0 in eFloras.org, Missouri Botanical Garden. Accessed Nov 12, 2008.
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Flora of Pakistan @ eFloras.org
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Distribution

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Distribution: North Africa, Mediterranean Region, Middle East, Central Asia, W. Pakistan; adventive in N. America.
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Missouri Botanical Garden, 4344 Shaw Boulevard, St. Louis, MO, 63110 USA
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Flora of Pakistan Vol. 0 in eFloras.org, Missouri Botanical Garden. Accessed Nov 12, 2008.
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Flora of Pakistan @ eFloras.org
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Habitat & Distribution

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Cultivated. Xinjiang [possibly native to SW Asia and the Mediterranean region].
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Flora of China Vol. 14: 75 in eFloras.org, Missouri Botanical Garden. Accessed Nov 12, 2008.
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Flora of China @ eFloras.org
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Wu Zhengyi, Peter H. Raven & Hong Deyuan
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Brief Summary

provided by EOL authors
Cumin (Cuminum cyminum) is probably native to Egypt, Central Asia, and the eastern Mediterranean region. Today it is grown in Iran, India, Morocco, China, Russia, Indonesia, Japan, and Turkey. It is used in curries, for pickling, for sauerkraut, in soups, and in stews. It is widely used in Latin America. (Vaughan and Geissler 1997) Cumin is a member of the carrot family (Apiaceae or Umbelliferae). It is a small, slender, branching annual herb, around 30 cm tall. The leaves are divided into several thread-like segments up to 5 cm in length. The small white or pink flowers are borne in few-flowered umbels with thread-like bracts. The fruit is 4 to 8 mm in length and grayish green to dark gray in color. Black Cumin (Nigella sativa) is in an entirely different family (Ranunculaceae, the buttercup family). (Vaughan and Geissler 1997)
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Comprehensive Description

provided by North American Flora
Cuminum cyminum L. Sp. PI. 254. 1753
Ligusticum Cuminum Crantz, Class. Umbell. 82. 1767. Luerssenia Cyminum Kuntze. Rev. Gen. 1: 268. 1891. Selinum Cuminum E. H. L. Krause in Sturm, Fl. Deuts. ed. 2. 12: 91. 1904.
Annual, glabrous, 2-3 dm. high; basal leaves ovate in general outline, excluding the petioles 5-10 cm. long, ternately dissected, the ultimate divisions linear-filiform, entire, 1-5 cm. long; petioles 1-2 cm. long; peduncles 3-10 cm. long; involucre of 5-7 linear and entire or ternate bracts with linear divisions, unequal, 1-5 cm. long, reflexed; involucel of bractlets like the bracts, 5-10 mm. long; rays 2-6, 5-25 mm. long, unequal; pedicels 2-8 mm. long; calyxteeth about 1 mm. long; petals white or rose; fruit oblong, 6-7 mm. long, 2.5-3 mm. broad; seed-face slightly concave. Type locality: "In Aegypto, Aethiopia," collector unknown.
Distribution: Mediterranean region; adventive in Texas.
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bibliographic citation
Albert Charles Smith, Mildred Esther Mathias, Lincoln Constance, Harold William Rickett. 1944-1945. UMBELLALES and CORNALES. North American flora. vol 28B. New York Botanical Garden, New York, NY
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Cumin

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Cumin (/ˈkjuːmɪn/[2][3] or US: /ˈkmɪn/,[2][4][5][6] or /ˈkʌmɪn/[2][3]) (Cuminum cyminum) is a flowering plant in the family Apiaceae, native to the Irano-Turanian Region.[7] Its seeds – each one contained within a fruit, which is dried – are used in the cuisines of many cultures in both whole and ground form. Although cumin is used in traditional medicine, there is no high-quality evidence that it is safe or effective as a therapeutic agent.[8]

Etymology

The term comes via Middle English and Old French from the Latin term cuminum. This in turn comes from the Ancient Greek κύμινον (kúminon), a Semitic borrowing related to Hebrew כמון (kammōn) and Arabic كمون (kammun). All of these ultimately derive from Akkadian 𒂵𒈬𒉡 (kamūnu).[9][10]

Description

Cumin seeds, about 5 mm.

Cumin is the dried seed of the herb Cuminum cyminum, a member of the parsley family. The cumin plant grows to 30–50 cm (12–20 in) tall and is harvested by hand. It is an annual herbaceous plant, with a slender, glabrous, branched stem that is 20–30 cm (8–12 in) tall and has a diameter of 3–5 cm (1+14–2 in).[11] Each branch has two to three sub-branches. All the branches attain the same height, so the plant has a uniform canopy.[11] The stem is colored grey or dark green. The leaves are 5–10 cm (2–4 in) long, pinnate or bipinnate, with thread-like leaflets. The flowers are small, white or pink, and borne in umbels. Each umbel has five to seven umbellets.[11] The fruit is a lateral fusiform or ovoid achene 4–5 mm (1615 in) long, containing two mericarps with a single seed.[11] Cumin seeds have eight ridges with oil canals.[11] They resemble caraway seeds, being oblong in shape, longitudinally ridged, and yellow-brown in color, like other members of the family Apiaceae (Umbelliferae) such as caraway, parsley, and dill.[12]

Confusion with other spices

Black cumin seeds
Caraway fruits are similar in shape and structure to cumin seeds

Cumin is sometimes confused with caraway (Carum carvi), another spice in the parsley family (Apiaceae). Many European languages do not distinguish clearly between the two. Many Slavic and Uralic languages refer to cumin as "Roman caraway" or "spice caraway". The distantly related Bunium persicum and Bunium bulbocastanum and the unrelated Nigella sativa are both sometimes called black cumin (q.v.).[13]

History

Cuminum cyminum Linn
Cumin essential oil in clear glass vial

Likely originating in Central Asia, Southwestern Asia, or the Eastern Mediterranean,[14][15] cumin has been in use as a spice for thousands of years.[13] Seeds of wild cumin were excavated in the now-submerged settlement of Atlit-Yam, dated to the early 6th millennium BC.[7] Seeds excavated in Syria were dated to the second millennium BC.[16] They have also been reported from several New Kingdom levels of ancient Egyptian archaeological sites.[14][15] In the ancient Egyptian civilization, cumin was used as a spice and as a preservative in mummification.[11][15]

Cumin was a significant spice for the Minoans in ancient Crete. Ideograms for cumin appear in Linear A archive tablets documenting Minoan palace stores during the Late Minoan period.[17] The ancient Greeks kept cumin at the dining table in its own container (much as pepper is frequently kept today), and this practice continues in Morocco. Cumin was also used heavily in ancient Roman cuisine.[18] In India, it has been used for millennia as a traditional ingredient in innumerable recipes, and forms the basis of many other spice blends.[8]

Cumin was introduced to the Americas by Spanish and Portuguese colonists. Black and green cumin are used in Persian cuisine. Today, the plant is mostly grown in the Indian subcontinent, Northern Africa, Mexico, Chile, and China.[13] Since cumin is often used as part of bird food and exported to many countries, the plant can occur as an introduced species in many territories.[19]

Cultivation and production

Ground cumin on display at the market in Ortigia, Syracuse (Italy)
Commercially packaged whole and ground cumin seeds
Jeera (cumin) rice, an Indian dish

Cultivation areas

India is the world's largest producer of cumin, accounting for about 70%. The other major cumin-producing countries are Syria (13%), Turkey (5%), UAE (3%), and Iran.[20] India produced 856,000 tons of cumin seed in 2020–2021 fiscal year.[21]

Climatic requirements

Cumin is a drought-tolerant tropical or subtropical crop. It is vulnerable to frost and has a growth season of 120 frost-free days.[22] The optimum growth temperature ranges are between 25 and 30 °C (77 and 86 °F).[11] The Mediterranean climate is most suitable for its growth. Cultivation of cumin requires a long, hot summer of three to four months. At low temperatures, leaf color changes from green to purple. High temperature might reduce growth period and induce early ripening. In India, cumin is sown from October until the beginning of December, and harvesting starts in February.[11] In Syria and Iran, cumin is sown from mid-November until mid-December (extensions up to mid-January are possible) and harvested in June/July.[11]

Grading

The three noteworthy sorts of cumin seed in the market vary in seed shading, amount of oil, and flavor.[23]

Cultivation parameters

Cumin is grown from seeds. The seeds need 2 to 5 °C (36 to 41 °F) for emergence, an optimum of 20–30 °C (68–86 °F) is suggested. Cumin is vulnerable to frost damage, especially at flowering and early seed formation stages.[11] Methods to reduce frost damage are spraying with sulfuric acid (0.1%), irrigating the crop prior to frost incidence, setting up windbreaks, or creating an early-morning smoke cover.[11] The seedlings of cumin are rather small and their vigor is low. Soaking the seeds for 8 hours before sowing enhances germination.[11] For an optimal plant population, a sowing density of 12–15 kilograms per hectare (11–13 lb/acre) is recommended.[11] Fertile, sandy, loamy soils with good aeration, proper drainage, and high oxygen availability are preferred. The pH optimum of the soil ranges from 6.8 to 8.3.[11] Cumin seedlings are sensitive to salinity[24] and emergence from heavy soils is rather difficult. Therefore, a proper seedbed preparation (smooth bed) is crucial for optimal establishment of cumin.

Two sowing methods are used for cumin, broadcasting and line sowing.[11] For broadcast sowing, the field is divided into beds and the seeds are uniformly broadcast in this bed. Afterwards, they are covered with soil using a rake. For line sowing, shallow furrows are prepared with hooks at a distance of 20 to 25 cm (8 to 10 in). The seeds are then placed in these furrows and covered with soil. Line sowing offers advantages for intercultural operations such as weeding, hoeing, or spraying.[11] The recommended sowing depth is 1–2 cm and the recommended sowing density is around 120 plants per m2. The water requirements of cumin are lower than those of many other species.[11] Despite this, cumin is often irrigated after sowing to be sure that enough moisture is available for seedling development. The amount and frequency of irrigation depends on the climate conditions.[11]

Cultivation management

The relative humidity in the center of origin of cumin is rather low. High relative humidity (i.e. wet years) favors fungal diseases. Cumin is especially sensitive to Alternaria blight and Fusarium wilt. Early-sown crops exhibit stronger disease effects than late sown crops. The most important disease is Fusarium wilt, resulting in yield losses up to 80%.[11] Fusarium is seed- or soil-borne and it requires distinct soil temperatures for development of epidemics.[11] Inadequate fertilization might favor Fusarium epidemics.[11] Cumin blight (Alternaria) appears in the form of dark brown spots on leaves and stems.[11] When the weather is cloudy after flowering, the incidence of the disease is increased.[11] Another, but less important, disease is powdery mildew. Incidence of powdery mildew in early development can cause drastic yield losses because no seeds are formed.[11] Later in development, powdery mildew causes discolored, small seeds.[11]

Pathogens can lead to high reductions in crop yield. Cumin can be attacked by aphids (Myzus persicae) at the flowering stage. They suck the sap of the plant from tender parts and flowers. The plant becomes yellow, the seed formation is reduced (yield reduction), and the quality of the harvested product decreases. Heavily infested plant parts should be removed. Other important pests are the mites (Petrobia latens) which frequently attack the crop. Since the mites mostly feed on young leaves, the infestation is more severe on young inflorescences.[25]

The open canopy of cumin is another problem. Only a low proportion of the incoming light is absorbed. The leaf area index of cumin is low (about 1.5). This might be a problem because weeds can compete with cumin for essential resources such as water and light and thereby lower yield. The slow growth and a short stature of cumin favors weed competition additionally.[11] Two hoeing and weeding sessions (30 and 60 days after sowing) are needed for the control of weeds. During the first weeding session (30 days after sowing), thinning should be done, as well, to remove excess plants. The use of preplant or pre-emergence herbicides is very effective in India,[11] but this kind of herbicide application requires soil moisture for a successful weed control.[26]

Breeding

Cumin is a diploid species with 14 chromosomes (i.e. 2n = 14). The chromosomes of the different varieties have morphological similarities with no distinct variation in length and volume. Most of the varieties available today are selections.[11] The variabilities of yield and yield components are high. Varieties are developed by sib mating in enclosed chambers[11] or by biotechnology. Cumin is a cross-pollinator, i.e. the breeds are already hybrids. Therefore, methods used for breeding are in vitro regenerations, DNA technologies, and gene transfers. The in vitro cultivation of cumin allows the production of genetically identical plants. The main sources for the explants used in vitro regenerations are embryos, hypocotyl, shoot internodes, leaves, and cotyledons. One goal of cumin breeding is to improve its resistance to biotic (fungal diseases) and abiotic (cold, drought, salinity) stresses. The potential genetic variability for conventional breeding of cumin is limited and research about cumin genetics is scarce.[28]

Uses

Cumin seed is used as a spice for its distinctive flavor and aroma.[13][15] Cumin can be found in some cheeses, such as Leyden cheese, and in some traditional breads from France. Cumin can be an ingredient in chili powder (often Tex-Mex or Mexican-style) and is found in achiote blends, adobos, sofrito, garam masala, curry powder, and bahaarat, and is used to flavor numerous commercial food products.[8] In South Asian cooking it is often combined with coriander seeds in a powdered mixture called dhana jeera.

Cumin can be used ground or as whole seeds.[13][15] It imparts an earthy, warming and aromatic character to food, making it a staple in certain stews and soups, as well as spiced gravies such as curry and chili.[15] It is also used as an ingredient in some pickles and pastries.[29]

Traditional

In India, the seeds are powdered and used in different forms such as kashaya (decoction), arishta (fermented decoction), and vati (tablet/pills), and processed with ghee (a semifluid clarified butter). In traditional medicine practices of several countries, dried cumin seeds are believed to have medicinal purposes,[8] although there is no scientific evidence for any use as a drug or medicine.[8]

Volatiles and essential oil

Cuminaldehyde, cymene, and terpenoids are the major volatile components of cumin oil which is used for a variety of flavors, perfumes, and essential oil.[13][30] Cumin oil may be used as an ingredient in some cosmetics.[31]

Aroma

Cumin's flavor and warm aroma are due to its essential oil content, primarily the aroma compound, cuminaldehyde.[30] Other aroma compounds of toasted cumin are the substituted pyrazines, 2-ethoxy-3-isopropylpyrazine, 2-methoxy-3-sec-butylpyrazine, and 2-methoxy-3-methylpyrazine. Other components include γ-terpinene, safranal, p-cymene, and β-pinene.[32][33][34]

Nutritional value

In a 100-g reference amount, cumin seeds provide high amounts of the Daily Value for fat (especially monounsaturated fat), protein, and dietary fiber (table). B vitamins, vitamin E, and several dietary minerals, especially iron, magnesium, and manganese, are present in substantial Daily Value amounts (table). Cumin seeds contain petroselinic acid.[30][35]

References

  1. ^ "Cuminum cyminum". Germplasm Resources Information Network (GRIN). Agricultural Research Service (ARS), United States Department of Agriculture (USDA). Retrieved 13 March 2008.
  2. ^ a b c "Definition of CUMIN".
  3. ^ a b Article title
  4. ^ Reidy, Jamie (8 October 2009). BACHELOR 101: Cooking + Cleaning = Closing. ISBN 9780578034638.
  5. ^ Sheen, Barbara (7 February 2012). Foods of Indonesia. ISBN 9780737759501.
  6. ^ Stanway, Penny (27 October 2009). Miracle of Spices: Practical Tips for Health, Home and Beauty. ISBN 9781780286341.
  7. ^ a b Kislev, Mordechai E.; Hartmann, Anat; Galili, Ehud (1 September 2004). "Archaeobotanical and archaeoentomological evidence from a well at Atlit-Yam indicates colder, more humid climate on the Israeli coast during the PPNC period". Journal of Archaeological Science. 31 (9): 1301–1310. doi:10.1016/j.jas.2004.02.010. ISSN 0305-4403.
  8. ^ a b c d e "Cumin". Drugs.com. 2018. Retrieved 24 February 2018.
  9. ^ "CUMIN | Meaning & Definition for UK English". Lexico.com. Archived from the original on 14 January 2020. Retrieved 27 February 2022.
  10. ^ Heinrich Zimmern (1915) Akkadische Fremdwörter als Beweis für babylonischen Kultureinfluss (in German), Leipzig: A. Edelmann, page 57
  11. ^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac Sastry EV, Anandaraj M. "Cumin, Fennel and Fenugreek" (PDF). Soils, Plant Growth and Crop Production. Encyclopedia of Life Support Systems. Retrieved 29 November 2013.
  12. ^ Słowianek, Marta; Majak, Iwona; Leszczyńska, Joanna; et al. (2020). "New allergens from spices in the Apiaceae family: anise Pimpinella anisum L. and caraway Carum carvi L." Central-European Journal of Immunology. 45 (3): 241–247. doi:10.5114/ceji.2020.101236. ISSN 1426-3912. PMC 7790001. PMID 33437175.
  13. ^ a b c d e f "Cumin". Encyclopaedia Britannica. 2018. Retrieved 24 February 2018.
  14. ^ a b Zohary D, Hopf M (2000). Domestication of plants in the Old World (first ed.). Oxford: Oxford University Press. p. 206.
  15. ^ a b c d e f Nabhan GP (2014). Cumin, Camels, and Caravans: A Spice Odyssey. Univ of California Press. p. 234. ISBN 978-0-520-26720-6.
  16. ^ Pickersgill, Barbara (2005). Prance, Ghillean; Nesbitt, Mark (eds.). The Cultural History of Plants. Routledge. p. 162. ISBN 0415927463.
  17. ^ Castleden, Rodney, "Minoans: Life in Bronze Age Crete”, Routledge, London & New York, 1990, p.52.
  18. ^ "Cumin: The Ancient Spice That's Traveled The Globe". KPBS Public Media. 11 March 2015. Retrieved 7 June 2022.
  19. ^ Bird Seed Aliens in Britain
  20. ^ Rahman, Azad; Akbar, Delwar; Surya, Bhattarai; et al. "Market Analysis of Cumin Seed". crcna.com.au. CRC for Developing Northern Australia. Retrieved 31 August 2021.
  21. ^ "Cumin : Area, Production and Productivity in India". dasd.gov.in. Directorate of Arecanut and Spices Development, Calicut. June 2021. Retrieved 31 August 2021.
  22. ^ "Cuminum cyminum (Cumin, Cummin, Jeera)". plants.ces.ncsu.edu; North Carolina Extension Gardener Plant Toolbox. North Carolina State University. Retrieved 24 December 2022.
  23. ^ "Cumin: commodity factsheet" (PDF). cips.org. Mintec. 2014. Archived from the original (PDF) on 9 March 2017. Retrieved 8 March 2017.
  24. ^ Bettaieb Rebey, Iness; Bourgou, Soumaya; Rahali, Fatma Zohra; Msaada, Kamel; Ksouri, Riadh; Marzouk, Brahim (1 April 2017). "Relation between salt tolerance and biochemical changes in cumin (Cuminum cyminum L.) seeds". Journal of Food and Drug Analysis. 25 (2): 391–402. doi:10.1016/j.jfda.2016.10.001. ISSN 1021-9498. PMC 9332532. PMID 28911682.
  25. ^ "Ericacea (Heath) Family and Their Culture". Penn State Extension. Retrieved 7 June 2022.
  26. ^ "Preemergence Herbicides, Dry Soils and Rain | Integrated Crop Management". crops.extension.iastate.edu. Retrieved 7 June 2022.
  27. ^ "Cumin Seed". FoodData Central, United States Department of Agriculture. 2017. Retrieved 24 February 2018.
  28. ^ Ebrahimie E, Habashi AA, Ghareyazie B, Ghannadha M, Mohammadie M (2003). "A rapid and efficient method for regeneration of plantlets from embryo explants of cumin (Cuminum cyminum)". Plant Cell, Tissue and Organ Culture. 75: 19–25. doi:10.1023/A:1024676507010. S2CID 13278163.
  29. ^ Kains MG (1912). Culinary Herbs: Their Cultivation Harvesting Curing and Uses. Orange Judd Company. Archived from the original on 4 March 2016.
  30. ^ a b c Bettaieb I, Bourgou S, Sriti J, Msaada K, Limam F, Marzouk B (August 2011). "Essential oils and fatty acids composition of Tunisian and Indian cumin (Cuminum cyminum L.) seeds: a comparative study". Journal of the Science of Food and Agriculture. 91 (11): 2100–7. doi:10.1002/jsfa.4513. PMID 21681765.
  31. ^ "Cumin". WebMD. 2019. Retrieved 28 August 2019.
  32. ^ Li R, Zi-Tao J (2004). "Chemical composition of the essential oil of Cuminum cyminum L. from China". Flavour and Fragrance Journal. 19 (4): 311–313. doi:10.1002/ffj.1302.
  33. ^ Wang L, Wang Z, Zhang H, Li X, Zhang H (August 2009). "Ultrasonic nebulization extraction coupled with headspace single drop microextraction and gas chromatography-mass spectrometry for analysis of the essential oil in Cuminum cyminum L". Analytica Chimica Acta. 647 (1): 72–7. doi:10.1016/j.aca.2009.05.030. PMID 19576388.
  34. ^ Iacobellis NS, Lo Cantore P, Capasso F, Senatore F (January 2005). "Antibacterial activity of Cuminum cyminum L. and Carum carvi L. essential oils". Journal of Agricultural and Food Chemistry. 53 (1): 57–61. doi:10.1021/jf0487351. PMID 15631509.
  35. ^ Hewlings, Susan J.; Kalman, Douglas S. (22 October 2017). "Curcumin: A Review of Its' [sic] Effects on Human Health". Foods. 6 (10): 92. doi:10.3390/foods6100092. ISSN 2304-8158. PMC 5664031. PMID 29065496.

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Cumin: Brief Summary

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Cumin (/ˈkjuːmɪn/ or US: /ˈkuːmɪn/, or /ˈkʌmɪn/) (Cuminum cyminum) is a flowering plant in the family Apiaceae, native to the Irano-Turanian Region. Its seeds – each one contained within a fruit, which is dried – are used in the cuisines of many cultures in both whole and ground form. Although cumin is used in traditional medicine, there is no high-quality evidence that it is safe or effective as a therapeutic agent.

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