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| ID | Type | Description | Link |
|---|---|---|---|
| 2025YFC3508004 | Other Grant/Funding Number | National Key Research and Development Program of China |
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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| Dongfang Hospital Beijing University of Chinese Medicine | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoston group | Active Comparator | Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily. |
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| Ba Zhen Yi Mu Pill and Ding Kun Dan group | Experimental | Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently. |
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| Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| traditional Chinese medicine | Drug | traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Danļ¼ |
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| Measure | Description | Time Frame |
|---|---|---|
| Menstrual patterns during treatment and after discontinuation | Document the number of episodes of menstruation during the treatment and follow-up period | From enrollment, during the treatment of 6 months, and within 3 months after treatment |
| 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-MĆ¼llerian Hormone (AMH). | from enrollment to the end of treatment at 6 months |
| Uterine volume | Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 Ć L Ć W Ć AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound. | From enrollment to the end of treatment at 6 months |
| Quality of Life Score(36-Item Short Form Health Surveyļ¼SF 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. | From enrollment to the end of treatment at 6 months |
| Total ovarian volume | Total ovarian volume (cmĀ³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 Ć length Ć width Ć thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound. | from enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to 3 months after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Diagnostic criteria for functional hypothalamic amenorrhea
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Deng, Doctor | Contact | 86+010-69158331 | yanndeng@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Shenyang Women's and Children's Hospital |
| UNKNOWN |
| Beijing University of Chinese Medicine Third Affiliated Hospital | UNKNOWN |
| Beijing University of Chinese Medicine | OTHER |
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| Western medicine | Drug | Western medicineļ¼Femoston 2/10) |
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| 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). |
| From enrollment to 3 months after the end of treatment |
| 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). | 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) | 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 | From enrollment to 3 months after the end of treatment |
| From enrollment to the end of treatment at 6 months |
| 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). | From enrollment to 3 months after the end of treatment. |
| 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) . | From enrollment to 3 months after the end of treatment |
| 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) . | From enrollment to 3 months after the end of treatment |