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Efficacy and safety of Jingqianshu granules in patients with premenstrual syndrome: a multicenter, randomized, double-blind, placebo-controlled trial

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Abstract

Introduction

Premenstrual syndrome (PMS) is a common disorder characterized by recurring somatic, emotional, and behavioral symptoms during the luteal phase of the menstrual cycle. Core manifestations include irritability, anxiety, insomnia, mood swings, breast tenderness, and headache. In Traditional Chinese Medicine (TCM), PMS with liver and qi stagnation is considered a pattern resulting from internal organ imbalance. Jingqianshu granules (JQS), a Chinese patented medicine, are traditionally used to soothe the liver, relieve depression, regulate qi, and alleviate pain.

Aim

This study aimed to evaluate the clinical efficacy and safety of JQS in women with PMS characterized by liver stagnation and qi stagnation.

Method

A total of 156 eligible participants were randomly assigned in a 2:1 ratio to receive JQS (n = 104) or placebo (n = 52) over three menstrual cycles, followed by a three-cycle post-treatment follow-up. The primary outcome was the change in the Daily Record of Severity of Problems (DRSP) scores. Secondary outcomes included TCM syndrome scores and improvements in individual symptoms. Safety was assessed by adverse event reporting and laboratory monitoring.

Results

The full analysis set (FAS) included 155 participants, and the per-protocol set (PPS) included 137. After three treatment cycles, DRSP scores were significantly reduced in the JQS group compared to placebo (FAS: − 14.3 ± 8.85 vs. − 10.1 ± 7.61; PPS: − 14.5 ± 8.61 vs. − 10.2 ± 7.13; both P < 0.001) with a moderate effect size (Cohen’s d = 0.51), indicating clinical relevance. TCM syndrome scores also showed greater improvement in the JQS group (FAS: 7.7 ± 3.11 vs. 9.0 ± 4.13; PPS: 7.7 ± 3.19 vs. 9.4 ± 4.23; P < 0.05). The JQS group exhibited significant improvements in individual DRSP symptoms including anxiety, fatigue, emotional instability, concentration difficulty, and breast tenderness (P < 0.05). Adverse events were mild and comparable between the groups (4.81% in JQS vs. 3.92% in placebo; P > 0.05), with no serious events reported.

Conclusion

Jingqianshu granules significantly alleviated PMS symptoms and demonstrated good tolerability, supporting their use as a safe and effective treatment option for women with liver and qi stagnation-type PMS.

Trial Registration

This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2200058599).

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

We would like to thank all participating patients and their families, as well as the researchers at all participating centers, for their contributions to the study.

Funding

None.

Author information

Authors and Affiliations

  1. Hebei University of Traditional Chinese Medicine, No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang, 050091, Hebei, China

    Zhenzhen Zhou & Huilan Du

  2. Anhui Provincial Hospital of Traditional Chinese Medicine, Hefei, 230000, China

    Weili Li & Wenjing Chen

  3. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China

    Yanfeng Liu

  4. Feicheng Hospital of Shandong Yiyang Health Group, Shandong, 271600, China

    Fujian Si

  5. Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, 250011, China

    Dongmei Wang

  6. Qinhuangdao Shanhaiguan Pharmaceutical Co., Ltd., Qinhuangdao, 066200, China

    Xu Sun & Nan Song

Contributions

Z Zhou: Writing the original draft, data curation, investigation. W Li: Supervision, Investigation. Y Liu: Supervision and Investigation. F Si: Supervision, Investigation. D Wang: Supervision, Investigation. X Sun: Supervision, Investigation. N Song: Supervision, Investigation. W Chen: Supervision, Investigation. H Du: Writing-review and editing, project administration, formal analysis.

Corresponding author

Correspondence to Huilan Du.

Ethics declarations

Conflicts of interest

Authors declare no conflicts of interest.

Ethics approval

This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the Good Clinical Practice Guidelines. The study protocol was reviewed and approved by the Ethics Committee of the Hebei University of Traditional Chinese Medicine (approval no. YXLL202203037. Approval date March 17, 2022).

Consent to participate

All participants provided written informed consent prior to enrollment in the trial.

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Zhou, Z., Li, W., Liu, Y. et al. Efficacy and safety of Jingqianshu granules in patients with premenstrual syndrome: a multicenter, randomized, double-blind, placebo-controlled trial. Int J Clin Pharm (2025). https://doi.org/10.1007/s11096-025-01949-5

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  • DOI  https://doi.org/10.1007/s11096-025-01949-5

Keywords

  • Chinese patent medicine
  • Jingqianshu granules
  • Liver stagnation and qi stagnation syndrome
  • Premenstrual syndrome
  • Randomized controlled trial
  • Traditional Chinese Medicine (TCM)

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