Effect of vitamin E with and without saffron on the sexual function in women of reproductive age with sexual dysfunction: a randomized controlled trial.

BACKGROUND: Sexual satisfaction is a crucial part of a fulfilled life, and the ability to have satisfying sexual function is crucial to one's sexual health. This study investigated the effect of the combined administration of saffron and vitamin E and vitamin E alone on the sexual function of women in their reproductive years. METHODS: A triple-blind randomized controlled trial was conducted with 50 participants experiencing sexual dysfunction without comorbid sleep disorders or severe depression. They were allocated into two groups using a block randomization method (stratified based on the severity of moderate or mild/normal depression). During the 8-week intervention period, participants in the experimental group were administered a 15 mg saffron capsule (safrotin) in the morning and a combination capsule containing 15 mg saffron and 50 mg vitamin E (safradide) in the evening. During the same period, the control group consumed one saffron placebo capsule in the morning and one capsule containing 50 mg of vitamin E and saffron placebo in the evening (in identical appearance to safradide). The Female Sexual Function Index was used to assess sexual function, and the Depression, Anxiety, and Stress Scale-21 (DASS-21) was used to measure levels of depression, anxiety, and stress. These measures were administered at baseline as well as four and eight weeks post-intervention, with an additional measurement taken four weeks after the intervention ceased. The repeated measures ANOVA, ANCOVA, and Mann-Whitney U tests were used to compare the groups. RESULTS: Following the intervention, the experimental group (saffron and vitamin E) demonstrated a statistically significant increase in the overall mean score of sexual function compared to the control group (placebo of saffron and vitamin E) (adjusted mean difference (AMD): 4.6; 95%CI: 3.1 to 6.1; p < 0.001). The mean scores for sexual function dimensions, namely libido, arousal, orgasm, and satisfaction, except for pain, were consistently higher than those of the control group across all time points (p < 0.001). Additionally, the mean score for lubrication was significantly higher only at the eighth-week measurement (p = 0.004). The mean depression score in the experimental group was significantly lower than in the control group at all-time points, i.e., four (p = 0.011) and eight weeks after the intervention (p = 0.005), and four weeks after the end of the intervention (p = 0.007). The experimental group exhibited a statistically significant decrease in mean anxiety score compared to the control group at four weeks into the intervention (p = 0.016) and four weeks following the end of the intervention (p = 0.002). At eight weeks post-intervention, however, there was no significant difference between the groups (p = 0.177). Additionally, the experimental group exhibited a significant reduction in the overall mean stress score compared to the control group after the intervention (AMD: -2.3; 95%CI: -3.1 to -1.5; p < 0.001). CONCLUSION: Using the combination of saffron and vitamin E is more effective in improving sexual function and its domains compared to vitamin E alone in women of reproductive age with sexual dysfunction without severe depression. Also, it diminishes the degree of depression, anxiety, and stress more compared to vitamin E alone. However, further research is required to arrive at a more definitive conclusion. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20100414003706N36. Date of registration: 17/05/2020; URL: https://en.irct.ir/trial/45992 ; Date of first registration: 21/05/2020.

MyKid'sNutrition mobile application trial: a randomized controlled trial to promote mothers' nutritional knowledge and nutritional status of preschool children with undernutrition-a study protocol.

BACKGROUND: Childhood malnutrition is a crucial public health issue in developing countries. Mothers' nutritional knowledge significantly affects children's nutritional status. It also appears that mothers with low health literacy are unable to adequately meet their children's nutritional needs because they do not clearly understand their children's nutrition and malnutrition status. METHODS: This randomized controlled trial aims to describe the development and study protocol of the MyKid'sNutrition application, a smartphone-based intervention for mothers of preschool (2-6 years old) children. The application contains several contents on children's healthy eating, childhood underweight, children's loss of appetite, and child growth assessment. As part of the MyKid'sNutrition trial, a total of 116 participants will be randomized 1:1 either to (a) treatment as usual and MyKid'sNutrition or (b) treatment as usual alone. The results of this trial will be based on changes in growth indicators and mothers' nutritional knowledge, attitude, and practice within the groups and the differences between them. DISCUSSION: Due to their widespread availability throughout society, smartphones can be used to deliver educational content on a large scale at a low cost. In addition, they can provide novel ways for patients to receive support. Hence, it is essential to conduct research studies on these types of interventions. MyKid'sNutrition application offers dietary solutions for such nutritional problems as underweight, loss of appetite, and malnutrition in children. Meanwhile, it provides detailed instructions on how to interact with the child. TRIAL REGISTRATION: IRCT.ir IRCT20140907019082N11. Registered on February 19, 2022.