traditional Chinese medicine: traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
Western medicine: Western medicine（Femoston 2/10)
Study 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
Sex
FEMALE
Min age
14 Years
Max age
40 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Menstrual patterns during treatment and after discontinuation — From enrollment, during the treatment of 6 months, and within 3 months after treatment Document the number of episodes of menstruation during the treatment and follow-up period
Sex hormone levels — from enrollment to the end of treatment at 6 months Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).
Uterine volume — From enrollment to the end of treatment at 6 months Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.
Quality of Life Score(36-Item Short Form Health Survey，SF 36) — From enrollment to the end of treatment at 6 months The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
Total ovarian volume — from enrollment to the end of treatment at 6 months Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
Recruiting
More Peking Union Medical College Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.