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Congratulations to Semaine for completing their clinical trial with Citruslabs
Raising the bar for supplements by rigorously studying them
Semaine is a PhD formulated women’s health company that offers plant-based non-pharmacological solutions to help women experience less painful periods. As endometriosis warriors, sisters Lauren and Catherine Lee experienced first hand that there were few options other than painkillers available - merely masking the pain rather than tackling the cause of it. Teaming up with Matt Crane, who brought in his background in bioengineering, the trio launched their first supplement - PMS & Period Support in 2020. To be taken seriously by the medical community and to provide women suffering from painful periods with a product grounded in evidence-based research, Semaine decided to run a clinical trial with Citruslabs.
About Semaine
Semaine is the natural solution for PMS and period relief.
The product
The dietary supplement (Semaine) tested in this trial includes:
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Vitamin D (as cholecalciferol from lichen),
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Magnesium (as magnesium oxide complexed with sunflower lecithin),
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Resveratrol (Polygonum cuspidatum (root) extract),
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Silybin phytosome (Silybum marianum (fruit) extract/sunflower lecithin),
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Green tea phytosome (Camellia sinensis (leaf) extract/sunflower lecithin),
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Curcumin phytosome (Curcuma longa (root) extract/sunflower lecithin),
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Quercetin phytosome (Sophora japonica (flower) extract/sunflower lecithin),
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Indian frankincense phytosome (Boswellia serrata (oleo-gum resin) extract/sunflower lecithin),
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Ashwagandha (Withania somnifera (root and leaf) extract).
Semaine pms & period support capsules
Study design
Semaine’s clinical trial was designed as an open-label crossover study and included hs-CRP inflammation markers performed through an at-home finger-prick blood test. In the study, participants were asked to first undergo one menstrual cycle without the product and then a second menstrual cycle with the product.
The participants
41 women aged 18-40 with PMS symptoms and menstrual symptoms, such as cramps, bloating, mood swings, fatigue, and body ache completed the trial. They completed a baseline wellbeing survey without intervention (no product) and an intervention wellbeing survey (in which the product was taken). The surveys were asking about the participants’ subjective well-being on PMS and menstrual symptoms. The participants also completed CRP blood tests on the same days of their baseline and intervention cycles. You can find more about study design on www.clinicaltrials.gov.
Abstract
Science-backed supplement with real results
The trial conducted was an open-label observational trial to study the effectiveness of the Semaine Health Company dietary supplement and its effect on common symptoms of normal menstrual discomfort.
Aims & Objectives: This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.
Study design: Interventional and observational.
Methods: Female participants, aged 18-40 were recruited for the trial. 59 women were initially contacted to be a part of the study with 41 completing the blood work and 48 completing the surveys at both baseline and intervention.
Results: The symptoms where participants experienced the most improvement included bloating (71%), cramping (73%), mood swings (73%), and GI issues (75%). These numbers indicate a significant perceived improvement from baseline to intervention, highlighting the effectiveness of the dietary supplement to improve common symptoms associated with menstruation.
Conclusion: This study provides evidence of the effectiveness of Semaine's proprietary supplement to reduce the perceived discomfort experienced by women before and during menstruation.
Results
This study provides evidence of the effectiveness of Semaine's proprietary supplement to reduce the perceived discomfort experienced by women before and during menstruation.
A majority of participants experienced improved symptoms from baseline to intervention. There was a significant reduction in all of the symptoms measured from baseline (without the supplement) to the intervention. The lower ratings were substantial and indicate that participants felt their symptoms were much improved when taking the supplement compared to not taking the supplement.
75% of study participants experienced fewer gastrointestinal issues
73% of study participants experienced less cramping
73% of study participants experienced fewer mood swings
73% of study participants experienced fewer bloating issues
73% reduction in NSAID and other pain relievers compared to basline
73% of study participants felt better overall
Assessing the effectiveness of the dietary supplement on blood biomarkers
Dependent t-tests were used to examine the differences between baseline and intervention levels of Vitamin D and CRP. There was no significant difference in levels of Vitamin D for participants from baseline to intervention (t = .76, p = .45, Cohen's d = .118). However, mean levels of Vitamin D did increase from baseline (M = 29.83) to post-intervention (M = 31.17). There was no significant difference in levels of CRP from baseline to the end of the intervention (t = 1.12, p = .27, Cohen's d = .18). CRP levels decreased on average from baseline measurement (M = 4.04) to post-intervention (M = 3.19). Overall, neither Vitamin D nor CRP reached statistical levels of significance in this trial, but both measures moved in the hypothesized direction from baseline to post-intervention.
Changes in Pain Relief Consumption Across the Trial
At baseline, 15 women reported taking some form of pain reliever to reduce the symptoms associated with menstruation. However, during the intervention time period, only 4 women reported consuming medication for pain relief. This drop from 15 to 4 participants needing medication represents a 73% reduction in NSAID and other pain reliever use during the intervention compared to the baseline.
About Citruslabs
Clinical trials for consumer brands
Citruslabs’ mission is to provide robust, affordable clinical trials for brands. We are setting new standards for creating research-backed product claims for supplements, skincare products, devices, CBD products, health foods, and superfoods.
Citruslabs’ mission is to provide robust, affordable clinical trials for brands. We are setting new standards for creating research-backed product claims for supplements, skincare products, devices, CBD products, health foods and superfoods.
We can do it all
Study design
IRB process
Patient recruitment
Patient adherence
Data collection
Data analysis
Product claims