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

Phase 4RecruitingNCT07606755

Tongji Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 55 Years

Medical Language ↔ Plain English

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;

Locations (3)

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

Outcomes

Primary Outcomes

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.

Time frame: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16

Secondary Outcomes

Hot flash scale (HFs)

The severity of hot flash was evaluated using visual analog scale (0-10).The higher the value, the more severe the symptoms.

Time frame: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16

Menopause-specific quality of life scale (MENQOL)

MENQOL contains 27 questions related to vasomotor symptoms, psychological symptoms, physiological symptoms, and sexual life. A lower MENQOL score indicates PMPS has a less influence on life quality.

Time frame: Week 0, Week 12, Week 16

Hamilton depressive scale (HAMD)

The items of HAMD are scored on a 5-level scale with 0-4 points, a few items is a 3-level scale with 0-2 points. A higher score indicates the more severe depression.

Time frame: Week 0, Week 12, Week 16

Hamilton anxiety scale (HAMA)

HAMA contains 14 items related to a number of anxiety symptoms. Each of items is scored on a 5-level scale with 0-4 points. A higher score indicates the more severe anxiety.

Time frame: Week 0, Week 12, Week 16

Vaginal Health Index (VHI)

The VHIS (Vaginal Health Index) comprises five assessment dimensions, each scored from 1 to 5 points, for a total of 25 points. A higher total score indicates better vaginal health, while a total score below 15 points suggests vaginal atrophy.

Time frame: Week 0, Week 12

TCM Syndrome Score Scale

Symptom severity will be graded according to the Guiding Principles for Clinical Research of New Chinese Medicines for eight TCM-specific symptom domains (hot flushes and sweating, menstrual irregularity, irritability, dizziness and headache, lumbar and knee soreness, insomnia with vivid dreaming, hypochondriac pain with bitter taste, and vaginal dryness), each rated 0-3 (absent/mild/moderate/severe). The total score is 24 points, with higher scores indicating more severe symptoms.

Time frame: Week 0, Week 12

Serum levels of sex hormones (E2, FSH, LH) and estrogen metabolites (2-OHE1,16α-OHE1)

Serum E2, FSH, and LH will be quantified by enzyme-linked immunosorbent assay (ELISA). Estrogen metabolites - 2-hydroxyestrone (2-OHE1) and 16α-hydroxyestrone (16α-OHE1) - will be determined by liquid chromatography-mass spectrometry (LC-MS).

Time frame: Week 0, Week 12

Serum inflammatory factors (IL-6, TNF-α)

Serum concentrations of interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α) will be measured by ELISA

Time frame: Week 0, Week 12

Intestinal microbiota β-GUS enzyme activity

β-GUS activity will be determined spectrophotometrically via the enzymatic hydrolysis of p-nitrophenyl-β-D-glucuronide (pNPG) to p-nitrophenol (pNP), quantified by absorbance at 405 nm.

Time frame: Week 0, Week 12

Short-Chain Fatty Acids (SCFAs)

Faecal concentrations of acetic acid, propionic acid, and butyric acid will be determined by gas chromatography.

Time frame: Week 0, Week 12

Gut Microbiota Analysis

Faecal samples will be collected at baseline and week 12. Participants will provide ≥5 mg of stool into a sterile collection tube, which will be immediately snap-frozen in liquid nitrogen and stored at -80°C pending analysis. Bacterial genomic DNA will be extracted using the QIAamp Swab DNA Kit (QIAGEN). The V3-V4 hypervariable regions of the 16S rRNA gene will be amplified by PCR and sequenced on the Illumina NextSeq 2000 platform.

Time frame: Week 0, Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts