Actively Recruiting
The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
Led by Peking Union Medical College Hospital · Updated on 2026-05-12
210
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
P
Peking University Third Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with functional hypothalamic amenorrhea
- Primary or secondary amenorrhea
- Normal or low FSH levels, LH less than 5 IU/L, E2 less than 50 pg/mL
- Amenorrhea not caused by organic hypothalamus or pituitary lesions, ovarian amenorrhea, uterine or genital tract abnormalities, drug-induced amenorrhea, or other causes
You will not qualify if you...
- Use of relevant medications within the past 3 months
- History of substance abuse or dependence (alcohol or drugs) within past 3 months
- Heavy smoking (20 or more cigarettes daily)
- Severe or unstable physical illnesses including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or blood disorders
- Psychiatric illness
- Lactating or pregnant women, or females within one year postpartum
- Allergy to study drugs or contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- Estrogen-sensitive tumors such as endometrial or breast cancer
- History of blood clots or thrombotic tendency
- Participation in another investigational drug trial within 1 month before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
Y
Yan Deng, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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