drugset / Trial / NCT07580950
The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
Phase 4
Recruiting
210 enrolled
Peking Union Medical College Hospital
Beijing University of Chinese Medicine · collabBeijing University of Chinese Medicine Third Affiliated Hospital · collabDongfang Hospital Beijing University of Chinese Medicine · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabPeking University Third Hospital · collabShenyang Women's and Children's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-10-22
- Primary completion
- 2028-06-30
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ba Zhen Yi Mu Pill | Unknown | 6 g | — |
| Subject | Dingkun Dan | Traditional medicine (herbal / TCM) | 7 g | — |
| Subject | Dydrogesterone | Other / unclassified | 10 mg | — |
| Subject | Estradiol | Other / unclassified | 2 mg | — |