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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 40
Healthy Volunteers: f
View:

⁃ Diagnostic criteria for functional hypothalamic amenorrhea

• primary or secondary amenorrhea

• Normal or low FSH levels, LH \< 5 IU/L, E2 \< 50 pg/mL

• Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract developmental abnormalities ,Drug-induced amenorrhea ,Other causes of amenorrhea

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Yan Deng, Doctor
yanndeng@163.com
86+010-69158331
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 210
Treatments
Active_comparator: Femoston group
Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.
Experimental: Ba Zhen Yi Mu Pill and Ding Kun Dan group
Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently.
Experimental: Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group
Participants in the intervention group received Ba Zhen Yi Mu Pill (6 g twice daily), Ding Kun Dan (7g twice daily), and Femoston (estradiol 2mg / dydrogesterone 10mg, 1 tablet daily) concurrently.
Related Therapeutic Areas
Sponsors
Collaborators: Shenyang Women's and Children's Hospital, Beijing University of Chinese Medicine, Peking University Third Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Beijing University of Chinese Medicine Third Affiliated Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov