Efficacy, safety and mechanism of Jinfeng pill in the treatment of perimenopausal syndrome: A protocol for a randomized, double-blind, placebo-controlled, multicenter trial.

@article{wu2026efficacy,
  title = {{Efficacy, safety and mechanism of Jinfeng pill in the treatment of perimenopausal syndrome: A protocol for a randomized, double-blind, placebo-controlled, multicenter trial.}},
  author = {Xiao Wu and Lishan Zhou and Jiaqi Hu and Man Tian and Shiqin Liu and Kunkun Song and Yufan Song and Xiaohu Xu},
  journal = {Contemporary clinical trials communications},
  year = {2026},
  month = oct,
  doi = {10.1016/j.conctc.2026.101704},
  url = {https://europepmc.org/article/MED/42999709},
  note = {CC BY-NC-ND},
}

TY  - JOUR
TI  - Efficacy, safety and mechanism of Jinfeng pill in the treatment of perimenopausal syndrome: A protocol for a randomized, double-blind, placebo-controlled, multicenter trial.
AU  - Xiao Wu
AU  - Lishan Zhou
AU  - Jiaqi Hu
AU  - Man Tian
AU  - Shiqin Liu
AU  - Kunkun Song
AU  - Yufan Song
AU  - Xiaohu Xu
PY  - 2026
DA  - 2026/10/26
JO  - Contemporary clinical trials communications
DO  - 10.1016/j.conctc.2026.101704
UR  - https://europepmc.org/article/MED/42999709
AB  - Perimenopausal syndrome (PMPS) refers to a series of physiological and psychological symptoms caused by the fluctuation or decline of sex hormone levels during the pre- and postmenopausal periods. With the acceleration of aging society, more and more women suffer from symptoms of PMPS. Jinfeng Pill (JFP) is a classic Chinese patent medicine for gynecological diseases, but it lacks rigorous clinical evidence for the treatment of PMPS. This randomized, double-blind, placebo-controlled, multicenter trial will be conducted across three hospitals in China. A total of 100 perimenopausal women will be randomly allocated in a 1:1 ratio to receive JFP or placebo for 12 weeks, followed by a 4-week post-treatment follow-up. The primary outcome is the modified Kupperman Index (KI), assessed at baseline and at weeks 4, 8, 12, and 16. Secondary outcomes include the Hot Flash scale (HFs), the Menopause-Specific Quality of Life (MENQOL) questionnaire, the Hamilton Depression Rating Scale (HAMD), the Hamilton Anxiety Rating Scale (HAMA), the Vaginal Health Index Score (VHIS), and Traditional Chinese Medicine (TCM) symptom score. Mechanistic outcomes encompass serum sex hormones and estrogen metabolites, inflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), gut microbiota composition (16S rRNA sequencing), faecal β-glucuronidase (β-GUS) activity, and short-chain fatty acid (SCFA) concentrations. This is the first multicenter, randomized, double-blind, placebo-controlled trial to investigate the molecular mechanism by which JFP ameliorate PMPS by reshaping the gut microbiota structure, modulating β-GUS activity, optimizing SCFAs metabolism, suppressing inflammatory responses, and maintaining estrogen homeostasis. The results of this trial will help us to evaluate the efficacy, safety and possible mechanism of JFP in treating PMPS. The protocol (Version 3.0, dated November 19, 2025) was approved by the Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (approval number: TJ-IRB202512083). Written informed consent will be obtained from all participants prior to enrolment. Findings will be disseminated through peer-reviewed publications and academic conference presentations. NCT07606755 (https://clinicaltrials.gov/study/NCT07606755).
SN  - 2451-8654
ER  -