Tehran University of Medical Sciences Traditional and Integrative Medicine 2476-5104 6 3 2021 09 19 236 248 Ahmad Reza Sharifi Olounabadi Medicine, Quran and Hadith Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran AND Department of Traditional Persian Medicine, School of Medicine, Shahed University, Tehran, Iran Fereidoun Khayyamfar Department of Urology, Faculty of Medicine, Shahed University, Tehran, Iran Mohammad Kamalinejad School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran Mahmood Salesi Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran Fatemeh Alijaniha Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran Fatemeh Emadi Department of Traditional Persian Medicine, School of Medicine, Shahed University, Tehran, Iran AND Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran Farzaneh Ghaffari School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Babak Daneshfard Integrative Medicine Research Unit, Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran Mohsen Naseri Department of Traditional Persian Medicine, School of Medicine, Shahed University, Tehran, Iran AND Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran AND Hikmat, Islamic and Traditional Medicine Department, The Academy of Medical Sciences, Tehran, Iran 2021 04 12 2021 06 09 Premature ejaculation is one of the most common sexual disorders worldwide without a satisfying treatment. In this study, we investigated the efficacy of a topical formulation of clove oil in premature ejaculation patients. Eligible patients were randomly divided into two groups to use either Syzygium aromaticum (SA) 1% gel or placebo gel 10 minutes before the intercourse for a period of 8 weeks. Outcome measurement were Premature Ejaculation Diagnostic Tool (PEDT) and International Index of Erectile Function (IIEF) questionnaires in addition to Intravaginal Ejaculation Latency Time (IELT). A total number of 22 (11 patients in each group) participants completed the study. At the end of the intervention, the IELT scores changed from 29.84 ± 18.59 to 97.09 ± 91.86 and 42.51 ± 13.98 to 52.45 ± 32.7 seconds in SA gel and placebo groups, respectively (p-value = 0.003). Also, the changes of PEDT scores in the SA gel group (from 14 ± 3.55 to 9.2 ± 4.56) comparing to that of placebo gel group (from 14.63 ± 3.61 to 13.5 ± 3.78) was significantly different (p-value =0.001). Moreover, results of IIEF questionnaire revealed significant improvement of “Intercourse Satisfaction” in SA gel group (p-value = 0.016). No adverse event was observed. It seems that SA gel could be beneficial in the treatment of premature ejaculation; however, it should be further evaluated in larger studies. https://jtim.tums.ac.ir/index.php/jtim/article/view/382