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

NCT07606755 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Perimenopausal Syndrome

Interventions

DRUG

Jinfeng Pill

Jinfeng Pill

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2028-05-01
Completion
2028-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07606755 on ClinicalTrials.gov