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RECRUITING
NCT07606755
PHASE4

Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

Perimenopausal syndrome (PMS) is a common condition affecting women during the transition to menopause, often causing hot flashes, sweating, insomnia, anxiety, depression, fatigue, and reduced quality of life. Current hormone replacement therapy can improve symptoms, but long-term use may increase the risk of breast cancer and cardiovascular complications. Therefore, safer and more effective alternative treatments are needed. Jinfeng Pill is a traditional Chinese medicine patented drug that has been widely used in gynecological disorders. Previous studies suggest that it may help regulate hormone balance, improve ovarian function, and reduce inflammation. Recent research has also shown that intestinal bacteria ("gut microbiota") may influence estrogen metabolism through the "gut microbiota-estrogen axis," which could play an important role in perimenopausal symptoms. This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of Jinfeng Pill in women with perimenopausal syndrome. Eligible participants will be randomly assigned to receive either Jinfeng Pill or a placebo for 12 weeks. Researchers will assess changes in menopausal symptoms, mood, sleep, and quality of life using standardized questionnaires and laboratory tests. In addition, the study will explore how Jinfeng Pill may regulate gut microbiota, β-glucuronidase (β-GUS) activity, short-chain fatty acids (SCFAs), inflammatory factors, and estrogen-related indicators. The findings may provide new evidence for the clinical use of traditional Chinese medicine in the treatment of perimenopausal syndrome and help clarify its underlying biological mechanisms.

Key Details

Gender

FEMALE

Age Range

45 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05-10

Completion Date

2028-05-01

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DRUG

Jinfeng Pill

Jinfeng Pill

DRUG

Placebo

Placebo

Locations (3)

Hubei Maternal and Child Health Hospital,Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan Children's Hospital (Wuhan Maternal and Child Health Hospital),Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China