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Clinical Trial
. 2025 Jul 12:17:2025-2038.
doi: 10.2147/IJWH.S521349. eCollection 2025.

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 Ferdinands  3
Affiliations
Clinical Trial

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 et al. Int J Womens Health. .

Abstract

Purpose: 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: clinical trial; dysmenorrhea; herbal medicine; menstrual disturbances.

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Conflict of interest statement

ALL is the managing director of Clinical Research Australia, a contract research organization that receives research funding from nutraceutical companies. ALL has also received presentation honoraria from nutraceutical companies. SJS is an employee of Clinical Research Australia. FRF is the head of research, co-founder, and CEO of Bioactive Natural Health Pty Ltd, the study funder and the manufacturer of the investigational product examined in this study. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Systematic illustration of study design.
Figure 2
Figure 2
Study steps and procedures.
Figure 3
Figure 3
Percentage Change in Mean Self-Ratings from Menstrual Period 1 to Menstrual Period 2 (Full Analysis Set).
See this image and copyright information in PMC

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