Functional Hypothalamic Amenorrhea
Conditions
Keywords
Functional Hypothalamic Amenorrhea, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial
Brief 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.
Interventions
DRUGtraditional Chinese medicine
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
DRUGWestern medicine
Western medicine（Femoston 2/10)
Sponsors
Peking Union Medical College Hospital
Peking University Third Hospital
Dongfang Hospital Beijing University of Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shenyang Women's and Children's Hospital
Beijing University of Chinese Medicine Third Affiliated Hospital
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10) | From enrollment to 3 months after the end of treatment | Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). |
| Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) | 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) . Total scores range from 0 to 78 , with higher scores indicating more disordered eating pathology (worse outcome) . A score of 20 or higher is considered indicative of an elevated risk for an eating disorder, warranting further clinical evaluation |
| Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) | From enrollment to 3 months after the end of treatment | Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome). |
| Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. | From enrollment to 3 months after the end of treatment | Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms (worse outcome). |
Countries
China
Contacts
CONTACTYan Deng, Doctor
Outcome results
None listed