Article · Volume 6, Issue 2 · pp. 34–37

Assessment of Nigella Sativa Induced Adverse Drug Reactions

Jaffar SM¹, Chandrasekhar KB², Padmanabha RY¹, Bushra S³

¹Department of Pharmacology, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur, Andhra Pradesh – 515721.
²Department of Chemistry, JNTU (a), Anantapur, Andhra Pradesh – 515002.
³Ayurvedic Physician, Nisa Clinic, M M Road, Adoni, Andhra Pradesh – 518301.

Abstract

Objective: Monitoring of Adverse Drug Reactions (ADRs) with intake of Nigella sativa was carried out in a primary care Ayurvedic hospital. Patients were counseled and information regarding their medical and medication history was taken.Methodology: The people who were using Nigella sativa as drug were followed for a period of 6 months prospectively. Naranjo's algorithm, WHO probability scale, Modified Hartwig and Seigel scale and Modified Shumock and Thornton scales were employed to assess the Causality, Severity and Preventability of the ADRs.Results: At the end of the study 22 ADRs were observed with the usage of Nigella sativa for the maintenance of normal health. Among the ADRs 45.45% were found Possible and 54.54% were found Probable (Naranjo's algorithm).Conclusion: In assessment of severity level all the ADRs (100%) were mild and definitely preventable. Even with these ADRs, the medication was not discontinued but dose adjustment was done in all the cases.

Keywords: Seeds; Nigella sativa; Adverse Drug Reactions; Alternate Medicine

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