Summary of Use during Lactation

Black seed (Nigella sativa) contains an essential oil containing a wide variety of terpenes, thymoquinone, beta-elemene and other many constituents. Black seed has been used orally as a galactogogue in India and Iran;[1-4] however, no scientifically valid clinical trials support this use in humans.[5] Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[6,7] The oil has also been used topically. No data exist on the excretion of any components of black seed into breastmilk or on the safety and efficacy of black seed in nursing mothers or infants. Limited information indicates that black seed is generally well tolerated. Black seed oil can cause allergic contact dermatitis.

Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

One hundred fifty-eight mothers in Iran of who reported difficulty in breastfeeding were given either a proprietary mixture of herbs (Shirafza Drop) or a chlorophyll solution as a placebo. The herbal mixture contained the purported galactogogues fennel, anise, cumin, black seed, and parsley. Infant ages ranged between 0 and 6 months and they were exclusively breastfed. Weight gain of the infants was measured over time. No difference in infant weight gain was seen between the two groups of infants.[8] Blinding and randomization in this study is unclear.

References

1.

Sayed NZ, Deo R, Mukundan U. Herbal remedies used by Warlis of Dahanu to induce lactation in nursing mothers. Indian J Tradit Knowl. 2007;6:602–5.

2.

Agrawala IP, Achar MVS, Boradkar RV, et al. Galactagogue action of Cuminum cyminum and Nigella sativa. Indian J Med Res. 1968;56:841–4. [PubMed: 5693882]

3.

Javan R, Javadi B, Feyzabadi Z. Breastfeeding: A review of its physiology and galactogogue plants in view of traditional Persian medicine. Breastfeed Med. 2017;12:401–9. [PubMed: 28714737]

4.

Dandotiya H, Singh G, Kashaw SK. The galactagogues use by Indian tribal communities to over come poor lactation. Int J Biotechnol Bioeng Res. 2013;4:243–8. http://www​.ripublication.com/ijbbr.htm

5.

Zulkefli AF, Idrus RBH, Hamid AA. Nigella sativa as a galactagogue: A systematic review. Sains Malays. 2020;49:1719–27. [CrossRef]

6.

Brodribb W. ABM Clinical Protocol #9. Use of galactogogues in initiating or augmenting maternal milk production, second revision 2018. Breastfeed Med. 2018;13:307–14. [PubMed: 29902083]

7.

Breastfeeding challenges: ACOG Committee Opinion, Number 820. Obstet Gynecol. 2021;137:e42–e53. [PubMed: 33481531]

8.

Shariati M, Mamoori GA, Khadivzade T. The survey of effect of using "Shirafza Drop" by nursing mothers on weight gain (WG) of 0-6 months exclusively breastfed. Horizon Med Sci. 2004;10:24–30.

Substance Name

Black Seed

Scientific Name

Nigella sativa

CAS Registry Number

90064-32-7

Drug Class

Breast Feeding

Lactation

Complementary Therapies

Phytotherapy

Plants, Medicinal