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Background <p>In the first days after childbirth, women often sleep less and have poorer sleep because of physiological and psychological changes and their new responsibilities. Given the side effects of chemical medications, herbal remedies are increasingly considered. This study aimed to determine the effect of fenugreek oral capsules on the sleep quality of primiparous women during the postpartum period.</p> Methods <p>This two-group, triple-blind, randomized controlled trial was conducted in 2023 on 60 primiparous women attending health centers in Sabzevar. Eligible women took either a 700&#xa0;mg fenugreek seed extract capsule or a 700&#xa0;mg placebo capsule containing Avicel powder once daily, starting on postpartum day 3,4, or 5 and continuing until day 60. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) before the intervention and on the 15th, 30th, and 60th days postpartum. Data were analyzed using SPSS (version 22) with descriptive and inferential statistical tests. A p-value of less than 0.05 was considered significant.</p> Result <p>Before the intervention, the mean sleep quality score was 12.7 ± 1.7 in the fenugreek group and 11.3 ± 2.1 in the placebo group. This difference was statistically significant (<i>p</i> = 0.009), indicating that the two groups were not fully comparable at baseline. On the 15th day postpartum, sleep quality scores were 11.3 ± 1.9 in the fenugreek group and 12.1 ± 1.4 in the placebo group, demonstrating no significant difference between the two groups. However, after adjusting for baseline differences using analysis of covariance, the difference in mean sleep quality score between the two groups became statistically significant (F = 17.1, df = 2, <i>p</i> &lt; 0.001). The average sleep quality scores in the intervention and placebo groups were 8.1 ± 1.5 and 10.0 ± 1.5, respectively, on the 30th day postpartum and 5.1 ± 1.4 and 8.9 ± 1.5, on the 60th day postpartum. The scores were significantly lower in the intervention group compared to the placebo group (<i>p</i> &lt; 0.001). Because the two groups differed in sleep quality scores before the intervention, analysis of covariance was performed. This analysis confirmed significant differences between the groups on postpartum days 30 and 60 (day 30: F = 21.4, df = 2, <i>p</i> &lt; 0.001; day 60: F = 54.6, df = 2, <i>p</i> &lt; 0.001).</p> Conclusion <p>Fenugreek oral capsule improved self-reported sleep quality of primiparous women during the postpartum period. Therefore, fenugreek may be an effective herbal option for improving sleep quality in primiparous postpartum women. However, future studies should use objective methods to assess sleep.</p> Trial registration <p>The current study has been registered in the Iran registry of clinical trials (<a href="http://www.irct.ir/">http://www.irct.ir/</a>) on the date 14-03-2023 with registration no. IRCT20230306057640N1.</p>

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The effect of fenugreek oral capsule on the sleep quality of primiparous women in the postpartum period: a triple‑blind randomized controlled trial

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  • 发表日期：

    2026年8月4日

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  • Somayeh Mohammadi,
  • Fatemeh Zahra Karimi,
  • Roshanak Salari,
  • Seyed Reza Mazloom

摘要

Background

In the first days after childbirth, women often sleep less and have poorer sleep because of physiological and psychological changes and their new responsibilities. Given the side effects of chemical medications, herbal remedies are increasingly considered. This study aimed to determine the effect of fenugreek oral capsules on the sleep quality of primiparous women during the postpartum period.

Methods

This two-group, triple-blind, randomized controlled trial was conducted in 2023 on 60 primiparous women attending health centers in Sabzevar. Eligible women took either a 700 mg fenugreek seed extract capsule or a 700 mg placebo capsule containing Avicel powder once daily, starting on postpartum day 3,4, or 5 and continuing until day 60. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) before the intervention and on the 15th, 30th, and 60th days postpartum. Data were analyzed using SPSS (version 22) with descriptive and inferential statistical tests. A p-value of less than 0.05 was considered significant.

Result

Before the intervention, the mean sleep quality score was 12.7 ± 1.7 in the fenugreek group and 11.3 ± 2.1 in the placebo group. This difference was statistically significant (p = 0.009), indicating that the two groups were not fully comparable at baseline. On the 15th day postpartum, sleep quality scores were 11.3 ± 1.9 in the fenugreek group and 12.1 ± 1.4 in the placebo group, demonstrating no significant difference between the two groups. However, after adjusting for baseline differences using analysis of covariance, the difference in mean sleep quality score between the two groups became statistically significant (F = 17.1, df = 2, p < 0.001). The average sleep quality scores in the intervention and placebo groups were 8.1 ± 1.5 and 10.0 ± 1.5, respectively, on the 30th day postpartum and 5.1 ± 1.4 and 8.9 ± 1.5, on the 60th day postpartum. The scores were significantly lower in the intervention group compared to the placebo group (p < 0.001). Because the two groups differed in sleep quality scores before the intervention, analysis of covariance was performed. This analysis confirmed significant differences between the groups on postpartum days 30 and 60 (day 30: F = 21.4, df = 2, p < 0.001; day 60: F = 54.6, df = 2, p < 0.001).

Conclusion

Fenugreek oral capsule improved self-reported sleep quality of primiparous women during the postpartum period. Therefore, fenugreek may be an effective herbal option for improving sleep quality in primiparous postpartum women. However, future studies should use objective methods to assess sleep.

Trial registration

The current study has been registered in the Iran registry of clinical trials (http://www.irct.ir/) on the date 14-03-2023 with registration no. IRCT20230306057640N1.