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

NCT07606755 | Recruiting Phase 4

• 1 other identifier: TJ-IRB202512083
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Perimenopausal Syndrome

Keywords

Perimenopausal Syndrome; Jinfeng Pill

Outcome Measures

Primary Outcomes (1)

• The modified Kupperman Index (KI)

  The total score of KI is 63. It includes 13 items related to peri-menopausal syndrome, and the severity score of each item ranges from 0 to 3. There were different basic score in each item: hot flashes and sweating = 4; Paresthesia, sleep disorders, nervousness, sexual complaints, urinary tract infection = 2; the other items = 1. Item score = basic score × severity score. Classification standard of disease condition: mild: symptom score \<13; moderate: symptom score 14-26; severe: symptom score \>27 points.

  Week -1, Week 0, Week 4, Week 8, Week 12, Week 16

Secondary Outcomes (11)

• Hot flash scale (HFs)

  Week -1, Week 0, Week 4, Week 8, Week 12, Week 16

• Menopause-specific quality of life scale (MENQOL)

  Week 0, Week 12, Week 16

• Hamilton depressive scale (HAMD)

  Week 0, Week 12, Week 16

• Hamilton anxiety scale (HAMA)

  Week 0, Week 12, Week 16

• Vaginal Health Index (VHI)

  Week 0, Week 12

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Jinfeng Pill group

EXPERIMENTAL

Jinfeng Pill

Drug: Jinfeng Pill

Interventions

Jinfeng Pill DRUG

Jinfeng Pill

Jinfeng Pill group

Placebo DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (3)

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

Wuhan, Hubei, 430000, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

Central Study Contacts

Xiaohu Xu

CONTACT

+8613006111902; hermanxu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 26, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)