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BackgroundCinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial.MethodsThis phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated.ResultsTwenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p < 0.05) and LDL-c (p < 0.001) was noted at the end of the 3 months follow up period. There were no serious adverse effects (including hypersensitivity) noted. In two participants dyspepsia necessitated the discontinuation of study participation. Drug compliance was between 85 and 95% during the study period.ConclusionsThis is the first phase I clinical trial in health adults evaluating efficacy and safety of CZ. Our results demonstrate no significant side effects and toxicity of CZ, including hepatotoxicity and anti-coagulation properties. CZ demonstrated beneficial anti-hyperlipidaemic and blood pressure lowering effects among healthy adults. Further studies with larger samples and longer durations may be able to elucidate other side effects and better describe the pharmacodynamic properties.Trial registrationSLCTR/2013/001 (Sri Lanka Clinical Trials Registry: http://www.slctr.lk/trials/106) (Date of Registration: 01/01/2013).

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Whole grains of rice [improved: Bw 361 (red) and Bg 359 (white); traditional: Kalu Heeneti (red) and Suwadal (white)], corn, finger millet, wheat, barley and oat were used in this study. Ethanolic extracts (EEs) and methanolic extracts (MEs) of whole grain cereals were evaluated for total polyphenolic content (TPC), ferric reducing antioxidant power (FRAP), oxygen radical absorbance capacity (ORAC), DPPH and ABTS radical scavenging antioxidant properties (AP) in vitro (n=3 each). Results showed significant differences (p<0.05) between extracts and among cereals for investigated AP. In general, MEs of cereals showed significantly higher (p<0.05) activity compared to EEs of cereals. Among the studied cereals, finger millet exhibited the highest AP in both extracts for TPC, FRAP and ORAC while for DPPH and ABTS it's only in MEs. The mean TPC, FRAP and ORAC of MEs of finger millet were 708.45 ± 11.72 mg gallic acid equivalents (GAE), 1413.69 ± 1.61, 1240.45 ± 67.38 mg Trolox equivalents (TE) and 955.76 ± 2.03 mg TEjl00 g grain, respectively while for EEs it was 275.36 ± 4.26 mg GAE, 606.34 ± 5.00 mg TE and 1112.52 ± 24.38 TEjl00 g grain respectively. For DPPH and ABTS radical scavenging activities the IC50 values of MEs of finger millet were 49.42 ± 6.65 and 10.74 ± 0.44 IlgjmL respectively. Ofthe cereals analyzed the second highest AP was observed in traditional red rice variety, Kalu Heeneti (except for ORAC) for both extracts tested. Whole grains of wheat and oats had very low AP compared to finger millet and red rice varieties analyzed in the present study. It is concluded that finger millet possesses highest AP.

The root extract of Salacia reticulata Wight (family: Celastraceae) is used in Sri Lanka by traditional practitioners as a herbal therapy for glycemic control even during pregnancy. It is recognized that some clinically used antidiabetic drugs have harmful effects on pregnancy but the effects of the S. reticulata root extract on reproductive outcome is unknown and deserves examination. We determined the effects of the S. reticulata root extract on the reproductive outcome of Wistar rats (250-260 g) when administered orally (10 g/kg) during early (days 1-7) and mid-(days 7-14) pregnancy. The root extract significantly (P<0.05) enhanced post-implantation losses (control vs treatment: early pregnancy, 4.7 ± 2.4 vs 49.3 ± 13%; mid-pregnancy, 4.7 ± 2.4 vs 41.7 ± 16.1%). Gestational length was unaltered but the pups born had a low birth weight (P<0.05) (early pregnancy, 6.8 ± 0.1 vs 5.3 ± 0.1 g; mid-pregnancy, 6.8 ± 0.1 vs 5.0 ± 0.1 g) and low birth index (P<0.05) (early pregnancy, 95.2 ± 2.4 vs 50.7 ± 12.9%; mid-pregnancy, 95.2 ± 2.4 vs 58.3 ± 16.1%), fetal survival ratio (P<0.05) (early pregnancy, 95.2 ± 2.4 vs 50.7 ± 12.9; mid-pregnancy, 95.2 ± 2.4 vs 58.3 ± 16.1), and viability index (P<0.05) (early pregnancy, 94.9 ± 2.6 vs 49.5 ± 12.5%; mid-pregnancy, 94.9 ± 2.6 vs 57.1 ± 16.1%). However, the root extract was non-teratogenic. We conclude that the S. reticulata root extract can be hazardous to successful pregnancy in women and should not be used in pregnancy complicated by diabetes.

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