Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome
ConditionPerimenopausal Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Jinfeng Pill
DrugJinfeng Pill
Placebo
DrugPlacebo
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: Jinfeng Pill groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Week -1, Week 0, Week 4, Week 8, Week 12, Week 16Secondary outcomes
1
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 162
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 163
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 164
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 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov