An Examination into the Safety and Efficacy of Khapregesic®, a Khaya Senegalensis Preparation, on Women Experiencing Menstrual Pain and Menstrual Distress: A Randomized, Double-Blind, Placebo-Controlled Trial

Adrian L Lopresti,1,2 Stephen J Smith,1 Frederick R Ferdinands3 1Clinical Research Australia, Perth, Western Australia, 6023, Australia; 2College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, 6150, Australia; 3Bioactive Natural Health Pty Ltd, Perth, Western Australia, 6014, AustraliaCorrespondence: Adrian L Lopresti, Clinical Research Australia, 38 Arnisdale Road Duncraig, Perth, Western Australia, 6023, Australia, Email [email protected]: In traditional medicine, Khaya senegalensis has been used to treat menstrual pain, dysmenorrhea, and digestive pain and discomfort. However, there are no human clinical trials examining its safety and efficacy for the treatment of menstrual distress. Therefore, the purpose of this two-arm, parallel-group, randomized, double-blind, placebo-controlled trial was to examine the safety and efficacy of supplementation with a Khaya senegalensis preparation (Khapregesic®) on menstrual pain and menstrual distress in menstruating women.Methods: Eighty-four women experiencing menstrual pain and distress were supplemented 3g daily with this Khaya senegalensis preparation or a placebo for one menstrual cycle. Changes in menstrual pain and other symptoms of menstrual distress were examined through daily ratings and validated self-report questionnaires. Moreover, changes in the use of rescue medications, C-reactive protein, and safety blood measures were examined.Results: Compared to the placebo, this Khaya senegalensis preparation was associated with greater reductions in daily menstrual pain ratings (p=0.033) and reductions in overall menstrual distress (p=0.042). Improvements in emotional wellbeing were also identified, along with reductions in the use of rescue medications, although this latter finding requires confirmation in future trials. No changes in C-reactive protein were identified. This Khaya senegalensis preparation was well-tolerated and there were no significant changes in safety blood markers.Conclusion: This study provides evidence supporting the safety and efficacy of a Khaya senegalensis preparation on menstrual pain and menstrual distress in women. Further investigations will be important to confirm and expand on the current findings and to help identify its potential mechanisms of action.Trial Registration: ANZCTR, ACTRN12624000731594p. Registered 14 June 2024, https://www.anzctr.org.au/ACTRN12624000731594p.aspx.Keywords: menstrual disturbances, dysmenorrhea, herbal medicine, clinical trial