Tolerability and safety of black cumin seed oil (Bcso) administration for 20 days in healthy subjects.

Akrom, Akrom and Darmawan, Endang (2017) Tolerability and safety of black cumin seed oil (Bcso) administration for 20 days in healthy subjects. Biomedical Research 2017; 28 (9): 4196-4201, 28 (9). pp. 4196-4201. ISSN 0970-938X

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Abstract

The objective of this research was to determine the effect of black cumin seed oil (BCSO) on hematology,
level of aspartat aminotransferase (AST)/alanin aminotransferase (ALT), level of ureum and creatinine,
and also immune response in healthy subjects. This study applied a phase 1 of clinical trial. The 36
healthy subjects were divided into three groups, 12 subjects each group. Group I, subjects received 1 × 3
soft capsules of BCSO. Group II, subject received 2 × 3 soft capsules of BCSO and in groups III subject
received 3 × 3 soft capsules of BCSO. Each soft capsule contained of 0.5 ml standardized BCSO. On the
21st day, the blood cell, level of ALT and AST and level of ureum and creatinine were measured. The
average number of blood cells, levels of ALT/AST and level of ureum and creatinine then were been
analyzed with one way ANOVA test. Statistical analysis was performed on 95% confidence level. The
results showed that the administration of three doses of BCSO soft capsule did not increase number of
blood cells, level of ALT/AST and level of ureum and creatinine (p>0.05). BCSO also did not affect
number of CD4+ Th and CD4+CD25+ Treg cells and also expression of IFN-γ (p>0.05). The
consumption of BCSO at three doses 1.5, 3, and 4.5 ml/d for 21 days in healthy subjects were tolerable
and safety

Item Type:	Artikel Umum
Keyword:	nigella sativa; tolerability; safety study; phase I clinical trial;
Subjects:	R Medicine > RM Therapeutics. Pharmacology
Divisi / Prodi:	Faculty of Pharmacy (Fakultas Farmasi) > Pharmacy Doc
Depositing User:	Akrom Akrom
Date Deposited:	22 Jan 2018 07:51
Last Modified:	22 Jan 2018 07:51
URI:	http://eprints.uad.ac.id/id/eprint/8610

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