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

BMC Complementary and Alternative Medicine

Research Article

Prasad Katulanda¹  Godwin Roger Constantine¹  Priyadarshani Galappaththy²  Shehani Pigera²  Priyanga Ranasinghe²  Wasundara Sevwandi Wathurapatha²  Ranil Jayawardena³  Hasitha Dhananjaya Weeratunga⁴  G. A. Sirimal Premakumara⁴ 

[1] Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka;Industrial Technology Institute, Colombo, Sri Lanka;

关键词: Cinnamomum zeylanicum;    Ceylon cinnamon;    Efficacy;    Pharmacodynamic;    Safety;    Adverse effects;    Sri Lanka;    Adults;   

DOI  :  10.1186/s12906-017-2067-7

 received in 2017-02-10, accepted in 2017-12-19,  发布年份 2017

来源: Springer

【 摘 要 】

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).

【 授权许可】

CC BY   
© The Author(s). 2017