An examination into the safety and efficacy of Khapregesic®, a Khaya senegalensis preparation, on physical and psychological wellbeing in women experiencing menopausal symptoms: a randomised, double-blind, placebo-controlled trial

Background Khaya senegalensis is a tree species that has traditional use for the alleviation of menstrual and hormonal symptoms in women. Moreover, supplementation with a Khaya senegalensis preparation (Khapregesic®) was associated with significant and rapid improvements in menstrual pain, mood, sleep, and fatigue in women with menstrual distress over 28 days. The present study aimed to assess the safety and efficacy of Khapregesic® over the same intervention period in women reporting menopausal symptoms across the transition from perimenopause to post-menopause. Methods In this 28-day, randomised, double-blind, placebo-controlled study, 140 peri- and postmenopausal women aged 42–62 years experiencing menopausal-related symptoms were supplemented with 2 grams daily of Khapregesic® or a matching placebo. Outcomes were assessed using validated self-report measures of menopausal symptoms (primary outcome: Greene Climacteric Scale), sleep disturbance/sleep-related impairment (PROMIS—Sleep Scale), fatigue (FACIT-Fatigue), vasomotor symptoms (hot flush rating scale), and digestive symptoms, alongside tolerability and safety monitoring. Results There were no statistically significant group differences in change scores across the primary and secondary outcomes. However, stratified analyses by menopausal stage indicated in postmenopausal women ( n = 69), Khapregesic® was associated with significantly greater improvements versus placebo in psychological symptoms ( p = 0.014), fatigue ( p = 0.045), and sleep disturbances ( p = 0.024). In contrast, no group differences were detected in perimenopausal women ( n = 71). Khapregesic® for 28 days was generally well tolerated, with a tendency towards transient, mild gastrointestinal symptoms. Conclusions Based on data from the full cohort, no statistically significant group effects were observed in this study. Subgroup analyses revealed positive improvements in post-menopausal but not perimenopausal women in mood/psychological symptoms, sleep disturbance, and fatigue. However, these secondary analyses should be considered tentative and require confirmation in future trials. Clinical Trial Registration : https://anzctr.org.au/ACTRN12625000247471p.aspx , identifier ACTRN12625000247471p.