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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 4

Conditions: Functional Hypothalamic Amenorrhea

Treatments: Drug: traditional Chinese medicine; Drug: Western medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT07580950

2025YFC3508004 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnostic criteria for functional hypothalamic amenorrhea

1. primary or secondary amenorrhea
2. Normal or low FSH levels, LH < 5 IU/L, E2 < 50 pg/mL
3. 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

1. Individuals who have used relevant medications within the past 3 months
2. History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
3. Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients
4. Lactating or pregnant women, or females within one year postpartum
5. History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
6. Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
7. History of thromboembolic disease or thrombotic tendency.
8. Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Femoston group

Active Comparator group

Description:

Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.

Treatment:

Drug: Western medicine

Ba Zhen Yi Mu Pill and Ding Kun Dan group

Experimental group

Description:

Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently.

Treatment:

Drug: traditional Chinese medicine

Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group

Experimental group

Description:

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.

Treatment:

Drug: Western medicine

Drug: traditional Chinese medicine