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

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.

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	2025-10-22
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-12