Shafa Ara Anjum 1Nikhat Kausar Inamdar 1Syeda Fatima Zohra 1Shaikh Saba Naaz Nasir Ahmed 1Pathan Sana Afroz 1Tabassum Kudchi 1Shazia Parveen Farooqui2
作者信息
- 1. Department of Niswan wa Qabalat(OBG),Luqman Unani Medical College Hospital and Research Centre,Naubag,Vijayapura 586101,Karnataka,India
- 2. Clinical Research Department,Regional Research Institute of Unani Medicine,Chennai 600013,Tamil Nadu,India
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摘要
Abstract
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 A.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 PMS at the Department of Ilm al-Qabalat Amrad-i Niswan,Luqman Unani Medi-cal 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.mille-folium(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 considered statistically significant.The findings demonstrated a signif-icant reduction in PMS symptoms and abdominal pain in the test group compared to the placebo group.Safety assessments and adverse event monitoring indicated that the intervention was well tolerated.The trial was started after registration with the Clinical Trials Registry of India CTRI/2024/07/071615 on August 12th 2024(URL:https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=112188&EncHid=24056.11844&modid=1&compid=19).
Results:After completion of the treatment protocol,the A.millefolium group demonstrated a significant reduction in mean PMTS-OR scores(P＜0.001),whereas the placebo group showed no meaningful improvement(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 PMS,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.关键词
千叶蓍/Achillea millefolium/经前综合征/PMTS-ORKey words
Achillea millefolium/PMS/PMTS-OR
