The Safety and Efficacy of Rosa Damascena Extract in Patients with Type II Diabetes: preliminary Report of a Triple Blind Randomized Acarbose Controlled Clinical Trial

Document Type: Original Article


1 Professor, Endocrinology and Metabolism Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran

2 Professor, Cardiovascular Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran

3 Assistant Professor, Endocrinologist, Physiology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran

4 Bachelor of Science in Honours Biology, University of British Colombia (UBC), Vancouver, BC, Canada


Background: Diabetes is a global health problem that its prevalence is increasing rapidly. Rosa damascena extract has shown to have an intensive non-competitive inhibitory effect on α-glucosidase in an animal study. The aim of this study was to assess the safety and efficacy of Rosa damascena (RD) Mill in diabetic patients and healthy subjects.
Methods: In a triple-blind, placebo and Acarbose-controlled randomized trial in Kerman in the south-east of Iran, we randomly allocated diabetic patients (n=32) and healthy volunteers (n=28) to 100mg Acarbose, 200 mg RD-methanolic extract, 400mg RD-methanolic extract and placebo groups. Over 15 days, the participants were followed up to monitor the changes in blood biochemical parameters and apparent symptoms. Analyses were carried out by intention to treat.
Results:RD extract decreased postprandial blood glucose levels comparable to the effects of Acarbose, demonstrating its α-glucosidase inhibitory activity. Besides, fasting plasma glucose levels significantly decreased in patients treated with 400 mg/day RD-methanolic extract compared to the 200 mg RD-methanolic extract (127.6±26.8vs. 165.5±27.1, p=0.041), suggesting that Rosa damascena Mill is effective in a dose dependent manner. No major or minor hypoglycemic event was observed. NO adverse event was observed in the RD treatment groups in comparison with Acarbose or placebo groups. Serum levels of biochemical parameters did not fluctuate significantly in RD treatment groups compared to Acarbose and placebo controls.
Conclusion:Rosa damascena not only decreases blood glucose levels, but also is safe to be used for the purpose of controlling blood glucose levels in drug naïve patients with type II diabetes.


  1. Najafipour H, Sanjari M, Shokoohi M, Haghdoost AA, Afshari M, Shadkam M, et al. Epidemiology of diabetes mellitus, pre-diabetes, undiagnosed and uncontrolled diabetes and its predictors in general population aged 15 to 75 years: A community-based study (KERCADRS) in southeastern Iran. J Diabetes. 2014:613-21.
  2. Sanjari M, Khodashahi M, Gholamhoseinian A, Shokoohi M. Association of adiponectin and metabolic syndrome in women. Journal of research in medical sciences: the official journal of Isfahan University of Medical Sciences. 2011;16(12):1532.
  3. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998;21(9):1414-31.
  4. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies. JAMA 1999;21(281):2005 – 12.
  5. De Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, et al. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med. 1995;333(19):1237-41.
  6. Lebovitz HE. Effect of the postprandial state on nontraditional risk factors. Am J Cardiol. 2001;88(6A):20H-5H.
  7. Ortiz-Andrade RR, Garcia-Jimenez S, Castillo-Espana P, Ramirez-Avila G, Villalobos-Molina R, Estrada-Soto S. alpha-Glucosidase inhibitory activity of the methanolic extract from Tournefortia hartwegiana: an anti-hyperglycemic agent. J Ethnopharmacol. 2007;109(1):48-53.
  8. Yeh GY, Eisenberg DM, Kaptchuk TJ, Phillips RS. Systematic review of herbs and dietary supplements for glycemic control in diabetes. Diabetes Care. 2003;26(4):1277-94.
  9. Shinde J, Taldone T, Barletta M, Kunaparaju N, Hu B, Kumar S, et al. a-Glucosidase inhibitory activity of Syzygium cumini (Linn.) Skeelsseed kernel in vitro and in Goto-Kakizaki(GK)rats. Carbohydrate 2008;343:1278 – 81.
  10. Gholamhoseinian A, Fallah H, Sharififar F, Mirtajaddini M. The inhibitory effect of some Iranian plants extracts on the alpha glucosidase. Iranian J Basic Med Sci 2008;11(1):1 - 9.
  11. Gholamhoseinian A, Fallah H, Sharifi far F. Inhibitory effect of methanol extract of Rosa damascena Mill. flowers on alpha-glucosidase activity and postprandial hyperglycemia in normal and diabetic rats. Phytomedicine. 2009;16(10):935-41.
  12. Rakhshandah H, Hosseini M, Dolati K. Hypnotic effect of Rosa damascena in mice. Iranian Journal of Pharmaceutical Research. 2004;3(3):181-5.
  13. Rakhshandah H, Hosseini M. Potentiation of pentobarbital hypnosis by Rosa damascena in mice. Indian J Exp Biol. 2006;44(11):910-2.
  14. Tabrizi H, Mortazavi S, Kamalinejad M. An in vitro evaluation of various Rosa damascena flower extracts as a natural antisolar agent. International journal of cosmetic science. 2003;25(6):259-65.
  15. Mahmood N, Piacente S, Pizza C, Burke A, Khan AI, Hay AJ. The anti-HIV activity and mechanisms of action of pure compounds isolated from Rosa damascena. Biochem Biophys Res Commun. 1996;229(1):73-9.
  16. ÖZKAN G, SAGDIC O, BAYDAR N, BAYDAR H. Antioxidant and antibacterial activities of Rosa damascena flower extracts. Food science and technology international. 2004;10(4):277-81.
  17. Zarghami M, Farzin D, Bagheri K. Anti depressant effects of Rosa Damascena on laboratory rats (A controlled experimental blind study). Journal of Mazandaran University of Medical Sciences. 2002;33:27 - 33.
  18. Shafei MN, Rakhshandah H, Boskabady MH. Antitussive effect of Rosa damascena in guinea pigs. Iranian Journal of Pharmaceutical Research. 2003;4:231-4.
  19. Jafari M, Zarban A, Pham S, Wang T. Rosa damascena decreased mortality in adult Drosophila. J Med Food. 2008;11(1):9-13.
  20. Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.
  21. Vuksan V, Sievenpiper JL, Xu Z, Beljan-Zdravkovic U, Jenkins AL, Arnason JT, et al. Ginseng and diabetes: a new way to use an old medicine. CJDC. 2001;25:111 - 20.
  22. Vuksan V, Sievenpiper JL, Xu Z, Wong EY, Jenkins AL, Beljan-Zdravkovic U, et al. Konjac-Mannan and American ginsing: emerging alternative therapies for type 2 diabetes mellitus. J Am Coll Nutr. 2001;20(5 Suppl):370S-80S; discussion 81S-83S.
  23. Gao H, Huang YN, Gao B, Xu PY, Inagaki C, Kawabata J. a-Glucosidase inhibitory effect by the flower buds of Tussilago farfara L. Food Chem 2008;106:1195 - 201.
  24. Cole RA, Soeldner JS, Dunn PJ, Bunn HF. A rapid method for the determination of glycosylated hemoglobins using high pressure liquid chromatography. Metabolism. 1978;27(3):289-301.
  25. Mohammadi A, Fallah H, Gholamhosseinian A. Antihyperglycemic effect of Rosa damascena is mediated by PPAR. γ gene expression in animal model of insulin resistance (summer 2017). Iranian Journal of Pharmaceutical Research. 2017.
  26. Siyavash J, Masoumeh A, Beydolah S, Hamid N, Hossein F. Assessment of Safety and Therapeutic Efficacy of Rosa damascena L. and Quercus infectoria on Cardiovascular Performance of Normal and Hyperlipidemic Rabbits: Physiologically Based Approach. 2013.
  27. Nakhaee A, Sanjari M. Evaluation of effect of acarbose consumption on weight losing in non-diabetic overweight or obese patients in Kerman. Journal of research in medical sciences: the official journal of Isfahan University of Medical Sciences. 2013;18(5):391.