The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: traditional Chinese medicine, Western medicine.
- Who it may be relevant to
- Registry conditions: Functional Hypothalamic Amenorrhea. Basic parameters: 14 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug traditional Chinese medicine
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan） - Drug Western medicine
Western medicine（Femoston 2/10)
Primary outcome measures
- Menstrual patterns during treatment and after discontinuation [Time frame: From enrollment, during the treatment of 6 months, and within 3 months after treatment]
- Sex hormone levels [Time frame: from enrollment to the end of treatment at 6 months]
- Uterine volume [Time frame: From enrollment to the end of treatment at 6 months]
- Quality of Life Score(36-Item Short Form Health Survey，SF 36) [Time frame: From enrollment to the end of treatment at 6 months]
- Total ovarian volume [Time frame: from enrollment to the end of treatment at 6 months]
Secondary outcome measures (4)
- Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) [Time frame: From enrollment to 3 months after the end of treatment]
- Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. [Time frame: From enrollment to 3 months after the end of treatment]
- Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10) [Time frame: From enrollment to 3 months after the end of treatment]
- Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) [Time frame: From enrollment to 3 months after the end of treatment]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- Individuals who have used relevant medications within the past 3 months
- History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
- Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients
- Lactating or pregnant women, or females within one year postpartum
- History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
- History of thromboembolic disease or thrombotic tendency.
- Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07580950 · 2025YFC3508004 · 2025YFC3508004