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The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea

NCT07580950 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-05-12

No results posted yet for this study

Summary

This study aims to validate the efficacy and safety of the "two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe the liver, nourishing the essence, and reinforcing the vital essence and strengthening the primordial qi with Chinese medicine" through a nationwide randomized controlled clinical trial involving 210 cases. Guided by traditional Chinese medicine theory, the study will explore the mechanism of integrated Chinese and Western medicine in the treatment of functional hypothalamic amenorrhea through gut microbiota and metabolomics research.

Conditions

  • Functional Hypothalamic Amenorrhea

Interventions

DRUG

traditional Chinese medicine

traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）

DRUG

Western medicine

Western medicine（Femoston 2/10)

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Dongfang Hospital Beijing University of Chinese Medicine

    collaborator OTHER

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Shenyang Women's and Children's Hospital

    collaborator UNKNOWN

  • Beijing University of Chinese Medicine Third Affiliated Hospital

    collaborator UNKNOWN

  • Beijing University of Chinese Medicine

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580950 on ClinicalTrials.gov