Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Tongji Hospital
- Enrollment
- 100
- Locations
- 3
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 45-55 years;
- •Menstrual disorders (prolonged menstrual cycle or hypomenorrhea) lasting for more than 3 months, or amenorrhea for 2-12 months;
- •Presence of vasomotor symptoms (hot flashes, sweating), somatic symptoms (insomnia, fatigue, headache, paresthesia), psychological symptoms (anxiety, depression), or urogenital symptoms (dyspareunia, vaginal dryness, urinary tract infection);
- •Serum follicle-stimulating hormone (FSH) > 10 IU/L, or decreased estradiol (E2) levels;
- •No use of HRT or other medications for perimenopausal symptoms in the past 2 months;
- •Intact uterus and bilateral adnexa, not surgically removed;
- •Voluntary participation and signing of informed consent;
- •Modified Kupperman Index (KI score) ≥ 6, indicating mild or above symptoms.
Exclusion Criteria
- •Does not meet the inclusion criteria listed above;
- •Ovarian malignancy, ovarian or hysterectomy, premature ovarian failure, uterine fibroids ≥2 cm, severe breast hyperplasia;
- •Acute gynecological infectious diseases or other acute infectious diseases;
- •Severe liver or kidney dysfunction, or other serious systemic diseases;
- •Use of hormonal drugs or traditional Chinese medicine for treatment in the past 2 months;
- •Participation in other clinical trials;
- •Patients who did not adhere to the treatment protocol or withdrew from the trial;
Investigators
Xiaohu Xu
Clinical Professor
Tongji Hospital