Jinfeng Pill for perimenopausal syndrome in women aged 45–55

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a phase 4, randomized, double-blind, placebo-controlled trial evaluating the effectiveness of the Jinfeng Pill for perimenopausal syndrome in women aged 45–55. Participants have vasomotor, somatic, psychological, or urogenital symptoms and meet specific hormonal and menstrual criteria. The trial compares the Jinfeng Pill to placebo over a defined treatment period, with safety and symptom outcomes monitored. The study builds on prior data suggesting hormonal regulation and anti-inflammatory effects, while considering the gut microbiota–estrogen axis as a potential mechanism. Leading centers in Wuhan, China, are enrolling eligible participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged 45-55 years;
2. Menstrual disorders (prolonged menstrual cycle or hypomenorrhea) lasting for more than 3 months, or amenorrhea for 2-12 months;
3. 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);
4. Serum follicle-stimulating hormone (FSH) \> 10 IU/L, or decreased estradiol (E2) levels;
5. No use of HRT or other medications for perimenopausal symptoms in the past 2 months;
6. Intact uterus and bilateral adnexa, not surgically removed;
7. Voluntary participation and signing of informed consent;
8. Modified Kupperman Index (KI score) ≥ 6, indicating mild or above symptoms.

Exclusion Criteria:

1. Does not meet the inclusion criteria listed above;
2. Ovarian malignancy, ovarian or hysterectomy, premature ovarian failure, uterine fibroids ≥2 cm, severe breast hyperplasia;
3. Acute gynecological infectious diseases or other acute infectious diseases;
4. Severe liver or kidney dysfunction, or other serious systemic diseases;
5. Use of hormonal drugs or traditional Chinese medicine for treatment in the past 2 months;
6. Participation in other clinical trials;
7. Patients who did not adhere to the treatment protocol or withdrew from the trial;

Where it's running

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

Study contacts

• Study coordinator: Xiaohu Xu
• Email: hermanxu@163.com
• Phone: +8613006111902

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Wearable device to track perimenopausal and menopausal symptoms

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• Effects of a Lean Pork Diet on Heart Health in Perimenopausal Women

  This study tests if a diet high in lean pork can improve heart health and reduce hot flashes in overweight and obese women going through menopause compared to a plant-based diet.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.