I. Drug and Supplement Interactions
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Clinical Trials of Drug or Supplement Interactions
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No clinical trials of drug or supplement interactions were identified.
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Case Reports of Suspected Drug or Supplement Interactions
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No case reports of suspected drug or supplement interactions were identified.
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Animal Trials of Drug or Supplement Interactions
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No animal trials of drug or supplement interactions were identified.
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Case Reports of Adverse Events
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No case reports of adverse events were identified.
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III. Pharmacology and Pharmacokinetics
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Human Pharmacological Studies
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In a randomized, placebo-controlled, crossover single-blind trial with type 2 diabetes volunteers, patients were administered 2.5 g of holy basil daily for 60 days. After treatment with holy basil, decreases in fasting and postprandial blood glucose levels were observed (Agrawal et al. 1996).
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Animal Pharmacological Studies
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In male rats orally administered 250 mg/kg of a benzene extract of holy basil daily for 48 days, a decrease in total sperm count, sperm motility, and forward velocity were observed along with an increase in abnormal sperm in caudal epididymal fluid. All parameters returned to normal within 2 weeks after cessation of treatment (Ahmed et al. 2002). In a related study with the same treatment regimen, changes in cells of the cauda epididymis were observed. After a fertility performance test, no implantations were observed in female rats mated with treated males (Ahmed et al. 2009).
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In male rats orally administered 100, 150, or 200 mg/kg of a benzene extract of holy basil, a reduction in sperm count, sperm motility, and testis weight was observed. No changes in weights of the epididymis, seminal vesicle, prostate, or vas deferens were observed (Seth et al. 1981).
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In male rats orally administered 100, 150, 200, or 400 mg/kg of holy basil extract daily for 15 days, a decrease in the sexual behavioral score was observed at the 200 and 400 mg/kg dose levels (Kantak and Gogate 1992).
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In male rats orally administered 0.2, 2, or 4 g/kg of holy basil, a reduction of sperm motility, number of successful matings, and resulting pregnancies were observed in male rats at the 2 and 4 g/kg doses (Khanna et al. 1986).
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A prolongation of the diestrus phase of the estrus cycle was observed in female rats orally administered 80 mg of fresh holy basil (average animal weight 200 g) daily for 2 weeks. In this study, effects were measured by observing reproductive behavior, and no hormone levels were measured (Sardessai et al. 1999).
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In diabetic rats orally administered 200 mg/kg of a dried ethanolic extract of holy basil daily for 30 days, a decrease in blood glucose levels was observed along with an increase in insulin levels and glucose tolerance (Narendhirakannan et al. 2006). A reduction in blood glucose levels was observed in diabetic rats orally administered 750 mg/kg of a dried ethanol extract of holy basil daily for 14 days (Kar et al. 2003). A reduction in blood glucose levels was observed in mice given 500 mg/kg of an aqueous extract of holy basil daily for 15 days (Gholap and Kar 2004). Other studies on holy basil in diabetic rats reported similar findings (Chattopadhyay 1993; Rai et al. 1997).
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In mice orally administered 500 mg/kg of a holy basil aqueous extract daily for 15 days, a reduction in serum thyroxine (T4) concentrations and glucose-6-phosphatase activity was observed. Serum levels of triiodothyronine (T3) and the T3/T4 ratio were unaffected (Panda and Kar 1998).
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In Vitro Pharmacological Studies
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No in vitro pharmacological studies were identified.
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IV. Pregnancy and Lactation
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A reduction in implantation was observed in female rats orally administered 200 mg/kg of an aqueous extract of holy basil daily on days 1 to 7 of pregnancy (Vohora et al. 1969).
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In female rats orally administered 0.2, 2, or 4 g/kg of holy basil, a reduction in the number of full-term pregnancies and the litter size were observed at the 2 and 4 g/kg dose levels (Khanna et al. 1986).
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No information on the safety of holy basil during lactation was identified.
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The LD50 of an alcohol extract of holy basil orally administered in mice is 1.54 mg/kg (Lagarto Parra et al. 2001).
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In the brine shrimp lethality assay, the LC50 of an alcohol extract of holy basil is 18.75 µg/ml (Lagarto Parra et al. 2001).
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Agrawal, P., V. Rai, and R.B. Singh. 1996. Randomized placebo-controlled, single blind trial of holy basil leaves in patients with noninsulin-dependent diabetes mellitus. Int. J. Clin. Pharmacol. Ther. 34(9):406-409.
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Ahmed, M., R.N. Ahamed, R.H. Aladakatti, and M.G. Ghosesawar. 2002. Reversible anti-fertility effect of benzene extract of Ocimum sanctum leaves on sperm parameters and fructose content in rats. J. Basic Clin. Physiol. Pharmacol. 13(1):51-59.
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Ahmed, M., R. Nazeer Ahamed, and R.H. Aladakatti. 2009. Effect of benzene extract of Ocimum sanctum leaves on cauda epididymis of albino rats. J. Basic Clin. Physiol. Pharmacol. 20(1):29-41.
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Chattopadhyay, R.R. 1993. Hypoglycemic effect of Ocimum sanctum leaf extract in normal and streptozotocin diabetic rats. Indian J. Exp. Biol. 31(11):891-893.
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Gholap, S., and A. Kar. 2004. Hypoglycaemic effects of some plant extracts are possibly mediated through inhibition in corticosteroid concentration. Pharmazie 59(11):876-878.
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Kantak, N.M., and M.G. Gogate. 1992. Effect of short term administration of tulsi (Ocimum sanctum Linn.) on reproductive behaviour of adult male rats. Indian J. Physiol. Pharmacol. 36(2):109-111.
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Kar, A., B.K. Choudhary, and N.G. Bandyopadhyay. 2003. Comparative evaluation of hypoglycaemic activity of some Indian medicinal plants in alloxan diabetic rats. J. Ethnopharmacol. 84(1):105-108.
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Khanna, S., S.R. Gupta, and J.K. Grover. 1986. Effect of long term feeding of tulsi (Ocimum sanctum Linn) on reproductive performance of adult albino rats. Indian J. Exp. Biol. 24(5):302-304.
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Lagarto Parra, A., R. Silva Yhebra, I. Guerra Sardinas, and L. Iglesias Buela. 2001. Comparative study of the assay of Artemia salina L. and the estimate of the median lethal dose (LD50 value) in mice, to determine oral acute toxicity of plant extracts. Phytomedicine 8(5):395-400.
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Narendhirakannan, R.T., S. Subramanian, and M. Kandaswamy. 2006. Biochemical evaluation of antidiabetogenic properties of some commonly used Indian plants on streptozotocin-induced diabetes in experimental rats. Clin. Exp. Pharmacol. Physiol. 33(12):1150-1157.
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Panda, S., and A. Kar. 1998. Ocimum sanctum leaf extract in the regulation of thyroid function in the male mouse. Pharmacol. Res. 38(2):107-110.
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Rai, V., U. Iyer, and U.V. Mani. 1997. Effect of tulasi (Ocimum sanctum) leaf powder supplementation on blood sugar levels, serum lipids and tissue lipids in diabetic rats. Plant Foods Hum. Nutr. 50(1):9-16.
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Sardessai, S.R., A.S. Borker, and M.E. Abraham. 1999. Effects of short term administration of tulsi leaves on sexual behaviour in female rats Indian J. Physiol. Pharmacol. 43(3):398-400.
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Seth, S.D., N. Johri, and K.R. Sundaram. 1981. Antispermatogenic effect of Ocimum sanctum. Indian J. Exp. Biol. 19(10):975-976.
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Vohora, S.B., S.K. Garg, and R.R. Chaudhury. 1969. Antifertility screening of plants. 3. Effect of six indigenous plants on early pregnancy in albino rats. Indian J. Med. Res. 57(5):893-899.
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