Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial

Abstract

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).

Effects of Cinnamon (Cinnamomum spp.) in Dentistry: A Review

“…Reports of allergic contact dermatitis and stomatitis as a result of cinnamon EOs are rare [ 53 , 54 ], which could lead to orofacial granulomatosis [ 55 ]. In vivo studies reported a lack of significant side effects on the liver and kidneys, no hypersensitivity, and a wide therapeutic range of C. zeylanicum [ 56 , 57 ]. C. zeylanicum has a positive osteogenesis effect on pulp stem cells [ 58 ].…”

Cinnamon extract inhibits allergen‐specific immune responses in human and murine allergy models

“…In humans, safety and efficacy of CE has been shown in several phase I clinical trials, mainly in patients with type II diabetes mellitus, where a significant decrease in fasting plasma glucose, total cholesterol, triglycerides, LDL cholesterol, glycosylated haemoglobin and blood pressure could be observed after receiving 1‐6 g of cinnamon capsules or powder daily for 40 days up to 4 months . Furthermore, cinnamon possessed therapeutic benefits on liver enzymes and high‐sensitivity C‐reactive protein in patients with non‐alcoholic fatty liver disease .…”

A Critical Review on the Role of Food and Nutrition in the Energy Balance

“…Cinnamon is obtained from different tree species of the genus Cinnamomum: Chinese cinnamon (Cinnamomum cassia or Cinnamomum aromaticum), coming from the East and containing high level of coumarin, with potential harmful effects [146]; and Ceylon cinnamon (Cinnamomum zeylanicum or Cinnamomum verum), coming from Sri Lanka and Madagascar, which contains only trace amounts of coumarin. Hepatotoxicity, effects of coumarin on coagulation and potential interference with drugs and mild adverse events have been reported for Chinese cinnamon, while, the consumption of Ceylon cinnamon seems safe [147][148][149].…”