Background Premenstrual Syndrome (PMS) is a cyclical condition that affects women’s physical, emotional, and social well-being. Conventional therapies may cause adverse effects, creating a need for safer options . Achillea millefolium , described in Unani medicine for its anti-inflammatory, antispasmodic, analgesic, and brain-tonic properties, is traditionally used to support emotional stability and gynaecological disorders. Objective This study aims to evaluates Achillea millefolium’s efficacy and safety compared with placebo in women with PMS through a randomized, doubleblind, placebo-controlled clinical trial. Methods This double-blind, randomized, placebo-controlled clinical trial was conducted on 50 women aged 18–40 years presenting with Premenstrual Syndrome (PMS) at the Department of Ilm al-Qabālat Amrāḍ-i Niswān, Luqman Unani Medical College Hospital and Research Centre, Vijayapura, Karnataka, India. This report follows the CONSORT 2025 guidelines. Out of 50 eligible patients, 6 were excluded and 44 participants were randomized into two groups, with 22 allocated to the test group and 22 to the control group. Participants in the test group received A. millefolium (500 mg, two capsules thrice daily from the 21st day of the menstrual cycle to the 3rd day of the next cycle), while the control group received an identical placebo according to the same regimen. Both interventions were administered for two consecutive cycles. Four participants (two from each group) were lost to follow-up, and the final analysis as per-protocol analysis was conducted on 40 participants who completed the study. The primary endpoint was reduction in PMS symptoms, assessed using the PMTS-OR scale, while secondary outcomes included changes in abdominal pain measured by the Visual Analogue Scale (VAS). Statistical analysis was performed using paired and unpaired t-tests, with P 0.05). The between-group difference indicated a clear therapeutic advantage of A. millefolium in alleviating PMS symptoms. Similarly, mean VAS scores declined markedly in the test group ( P < 0.001), with no significant change observed in the control group. No adverse events were reported during the study period. Conclusion A. millefolium demonstrated significant improvement in the physical, psychological, and behavioural manifestations of Premenstrual Syndrome, thereby enhancing overall quality of life. These findings suggest that A. millefolium may serve as a safe, effective, and affordable Unani therapeutic option for the management of PMS.
Anjum et al. (Mon,) studied this question.