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

2026년 5월 18일 업데이트: Xiaohu Xu, Tongji Hospital

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

100

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Hubei
      • Wuhan, Hubei, 중국, 430000
        • 모병
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 연락하다:
      • Wuhan, Hubei, 중국, 430000
        • 모병
        • Hubei Maternal and Child Health Hospital,Tongji Medical College of Huazhong University of Science and Technology
        • 연락하다:
      • Wuhan, Hubei, 중국, 430000
        • 모병
        • Wuhan Children's Hospital (Wuhan Maternal and Child Health Hospital),Tongji Medical College of Huazhong University of Science and Technology
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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;

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약 그룹
위약
의약품: 위약
위약
실험적: Jinfeng Pill group
Jinfeng Pill
의약품: Jinfeng Pill
Jinfeng Pill

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The modified Kupperman Index (KI)
기간: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
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

2차 결과 측정

결과 측정
측정값 설명
기간
Hot flash scale (HFs)
기간: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
The severity of hot flash was evaluated using visual analog scale (0-10).The higher the value, the more severe the symptoms.
Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
Menopause-specific quality of life scale (MENQOL)
기간: Week 0, Week 12, Week 16
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.
Week 0, Week 12, Week 16
Hamilton depressive scale (HAMD)
기간: Week 0, Week 12, Week 16
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.
Week 0, Week 12, Week 16
Hamilton anxiety scale (HAMA)
기간: Week 0, Week 12, Week 16
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.
Week 0, Week 12, Week 16
Vaginal Health Index (VHI)
기간: Week 0, Week 12
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.
Week 0, Week 12
TCM Syndrome Score Scale
기간: Week 0, Week 12
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.
Week 0, Week 12
Serum levels of sex hormones (E2, FSH, LH) and estrogen metabolites (2-OHE1,16α-OHE1)
기간: Week 0, Week 12
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).
Week 0, Week 12
Serum inflammatory factors (IL-6, TNF-α)
기간: Week 0, Week 12
Serum concentrations of interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α) will be measured by ELISA
Week 0, Week 12
Intestinal microbiota β-GUS enzyme activity
기간: Week 0, Week 12
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.
Week 0, Week 12
Short-Chain Fatty Acids (SCFAs)
기간: Week 0, Week 12
Faecal concentrations of acetic acid, propionic acid, and butyric acid will be determined by gas chromatography.
Week 0, Week 12
Gut Microbiota Analysis
기간: Week 0, Week 12
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.
Week 0, Week 12

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tongji Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 10일

기본 완료 (추정된)

2028년 5월 1일

연구 완료 (추정된)

2028년 5월 1일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 5월 18일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • TJ-IRB202512083

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Protecting participant privacy and data security.To consider potential data needs, please contact authorized researchers.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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