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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07580950
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Peking University Third Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shenyang Women's and Children's Hospital, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing University of Chinese Medicine
Conditions Functional Hypothalamic Amenorrhea
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov