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

Обзор

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.

Вмешательства

• Препарат Jinfeng Pill
  Jinfeng Pill
• Препарат Placebo
  Placebo

Первичные конечные точки

• The modified Kupperman Index (KI) [Срок оценки: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16]

Вторичные конечные точки (11)

• Hot flash scale (HFs) [Срок оценки: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16]
• Menopause-specific quality of life scale (MENQOL) [Срок оценки: Week 0, Week 12, Week 16]
• Hamilton depressive scale (HAMD) [Срок оценки: Week 0, Week 12, Week 16]
• Hamilton anxiety scale (HAMA) [Срок оценки: Week 0, Week 12, Week 16]
• Vaginal Health Index (VHI) [Срок оценки: Week 0, Week 12]
• TCM Syndrome Score Scale [Срок оценки: Week 0, Week 12]
• Serum levels of sex hormones (E2, FSH, LH) and estrogen metabolites (2-OHE1,16α-OHE1) [Срок оценки: Week 0, Week 12]
• Serum inflammatory factors (IL-6, TNF-α) [Срок оценки: Week 0, Week 12]
• Intestinal microbiota β-GUS enzyme activity [Срок оценки: Week 0, Week 12]
• Short-Chain Fatty Acids (SCFAs) [Срок оценки: Week 0, Week 12]
• Gut Microbiota Analysis [Срок оценки: Week 0, Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

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

Идентификаторы

NCT: NCT07606755 · TJ-IRB202512083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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