Hypnotic effects of a persian medicine intranasal preparation containing saffron, lettuce seeds and sweet violet in the treatment of the primary chronic insomnia: a randomized, double blind controlled

Behjat Javadi,1,* Hossein khaluyan,2 Zhila taherzadeh,3 Milad iranshahy,4

1. Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
3. 1Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
4. Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Ira

Abstract


Introduction

Hypnotic effects of a persian medicine intranasal preparation containing saffron, lettuce seeds and sweet violet in the treatment of the primary chronic insomnia: a randomized, double blind controlled clinical trial introduction: insomnia, insomnia is the most common sleep disorder that reduces quality of life. persian medicine has a number of recommendations for the treatment of insomnia. in the present randomized, double blind, placebo controlled clinical trial, we aim to evaluate the effectiveness of a intranasal drop containing a combination of violet oil, saffron oil and lettuce seeds oil (containing 0.02 mg/ml crocin and 4 µg/ml isoquercitrin) compared with the placebo (sesame oil).

Methods

Methods: this study was conducted as an experimental pretest-posttest evaluation in 50 patients with chronic insomnia in mashhad university of medical sciences, mashhad, iran. intervention and placebo groups received two drops in each nostril twice a day for eight weeks. all patients were required to fill an insomnia severity index (isi) and psqi questionnaire before the start of the trial and after 1, 4 and 8 weeks of treatment.

Results

Results: the reduction in the isi and psqi scores from baseline was significantly different between the two groups by the study endpoint (p≤0.01). between the baseline and week 8, the mean isi scores decreased significantly for the intervention group (p=0.001) and for the placebo group (p<0.01). moreover, the use of hypnotic drugs in the intervention group was significantly reduced (p<0.001), while hypnotics use in the placebo group was maintained at baseline level. no adverse effects were reported during the study

Conclusion

Conclusion: it seems that intranasal administration of the persian medicine recommended preparation can be used to alleviate chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients

Keywords

Persian medicine, violet, saffron, lettuce, traditional, insomnia