CLINICAL TRIAL article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1512110
Efficacy and safety of Kunxinning granules in patients with menopausal syndrome: A multicenter, randomized, double-blinded, and placebo-controlled trial
Provisionally accepted
Guirong Zhou1Danfei Chen2Lin Qian3Dianrong Song4Qin Zhang2Ying Yan3Jie Lin4Li Li5Guiping Wan6Shuping Li6Lili Hou7Yi He1*Cong Qi8
Weian Yuan9*- 1Tasly Pharmaceutical Group (China), Tianjin, China
- 2Zhejiang Research Institute of Traditional Chinese Medicine Co., Ltd., Hangzhou, Zhejiang Province, China
- 3Department of Nuclear Medicine, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
- 4Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Hebei, China
- 5Guangxing Hospital of Zhejiang Chinese Medical University, Hangzhou, Jiangsu Province, China
- 6Department of Traditional Chinese Medicine, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China
- 7Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
- 8Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu Province, China
- 9Department of Neonatology, Nanjing Maternal and Child Health Hospital, Nanjing, China
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Background: Menopausal syndrome is a general term for a series of physical and psychological symptoms that women experience during menopause and perimenopause, which can lead to the occurrence of a variety of diseases. Many ingredients in Kunxinning granules have been used clinically to treat menopausal syndrome. However, evidence for its effectiveness is lacking.Purpose: To investigate the efficacy and safety of Kunxinning Granules in patients with menopausal syndrome and to fully verify its clinical application value.Study design: A multicenter, randomized, double-blinded, placebo-controlled trial.Methods: Eligible participants from 9 hospitals were randomly assigned in a ratio of 3:1 to the experimental group (Kunxinning granules) and the placebo group (Kunxinning granules simulated agent) for 12 weeks. The primary efficacy outcome was the score reduction of the modified Kupperman index compared with the baseline.The secondary efficacy index is the disappearance rate of 13 single symptoms of the modified Kupperman index. The evaluation time points are baseline, 4 weeks, 8 weeks, 12 weeks and 4 weeks of drug withdrawal.Results: A total of 475 patients (356 in experimental group and 119 in placebo groups) were included in the analysis. The modified Kupperman index of patients in the experimental group and placebo group were 28.81±6.81 and 27.61±7.38. The modified Kupperman index of the experimental group improved after 4 weeks of treatment (experimental group: 21.45±6.29, placebo group: 23.79±6.90, 97.5%CI: -3.68 --0.99, p =0.007) and 8 weeks (experimental group: 15.18±5.82, placebo group: 20.93±7.29, 97.5%CI: -7.05 --4.45, p <0.0001), 12 weeks (experimental group:
Keywords: Full analysis set, Kunxinning granules, Menopausal Syndrome, modified ADR, adverse drug reactions, AE, adverse events, CI, confidence interval, FAS, Full Analysis Set, FSH, follicle-stimulating hormone
Received: 04 Nov 2024; Accepted: 23 Jun 2025.
Copyright: © 2025 Zhou, Chen, Qian, Song, Zhang, Yan, Lin, Li, Wan, Li, Hou, He, Qi and Yuan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yi He, Tasly Pharmaceutical Group (China), Tianjin, 300410, China
Weian Yuan, Department of Neonatology, Nanjing Maternal and Child Health Hospital, Nanjing, China
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