About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
traditional Chinese medicine
Drugtraditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan)
Western medicine
DrugWestern medicine(Femoston 2/10)
Treatment groups
Trial outcomes
Primary outcomes
Menstrual patterns during treatment and after discontinuation
Document the number of episodes of menstruation during the treatment and follow-up period
Sex hormone levels
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
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)
The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
Secondary outcomes
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
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.
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).
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
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)
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
Other outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Participants were followed up at the hospital every 3 months during the treatment period. At each follow-up visit, adverse events (AEs) were documented, and their causality (relationship to the treatment) was assessed by the investigators. The severity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Serum alanine aminotransferase (ALT) levels were measured to assess liver function. Elevated ALT levels indicate hepatocellular injury (worse outcome).
Renal function was assessed by measuring serum creatinine (SCr) levels
Renal function was assessed by measuring serum creatinine (SCr) levels. Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .
Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) . Total physical activity was calculated as metabolic equivalent of task (MET)-minutes per week, ranging from 0 to 14,280 MET-minutes/week (theoretical maximum), with higher scores indicating greater physical activity levels (better outcome) . Total sitting time was recorded as minutes per week, ranging from 0 to 1,440 minutes/week, with higher scores indicating more sedentary behavior (worse outcome) .
Sponsors and contacts
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Peking Union Medical College Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Dongfang Hospital Beijing University of Chinese Medicine
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Shenyang Women's and Children's Hospital
Collaborator
Beijing University of Chinese Medicine Third Affiliated Hospital
Collaborator
Beijing University of Chinese Medicine
Collaborator