The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
5 mai 2026 mis à jour par: Peking Union Medical College Hospital
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
210
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yan Deng, Doctor
- Numéro de téléphone: 86+010-69158331
- E-mail: yanndeng@163.com
Lieux d'étude
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-
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Beijing, Chine, 100730
- Recrutement
- Peking Union Medical College Hospital
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Contact:
- Yan Deng, Doctor
- Numéro de téléphone: 01069158331
- E-mail: yanndeng@163.com
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Chercheur principal:
- Aijun Sun, Doctor
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
Diagnostic criteria for functional hypothalamic amenorrhea
- 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
Exclusion Criteria:
- 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
- History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
- History of thromboembolic disease or thrombotic tendency.
- Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Femoston group
Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.
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Western medicine（Femoston 2/10)
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Expérimental: Ba Zhen Yi Mu Pill and Ding Kun Dan group
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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traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
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Expérimental: Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group
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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Western medicine（Femoston 2/10)
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Menstrual patterns during treatment and after discontinuation
Délai: From enrollment, during the treatment of 6 months, and within 3 months after treatment
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Document the number of episodes of menstruation during the treatment and follow-up period
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From enrollment, during the treatment of 6 months, and within 3 months after treatment
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Sex hormone levels
Délai: from enrollment to the end of treatment at 6 months
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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).
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from enrollment to the end of treatment at 6 months
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Uterine volume
Délai: 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.
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From enrollment to the end of treatment at 6 months
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Quality of Life Score(36-Item Short Form Health Survey，SF 36)
Délai: From enrollment to the end of treatment at 6 months
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The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
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From enrollment to the end of treatment at 6 months
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Total ovarian volume
Délai: from enrollment to the end of treatment at 6 months
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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.
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from enrollment to the end of treatment at 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Délai: From enrollment to 3 months after the end of treatment
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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).
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From enrollment to 3 months after the end of treatment
|
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Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Délai: From enrollment to 3 months after the end of treatment
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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).
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From enrollment to 3 months after the end of treatment
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Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
Délai: From enrollment to 3 months after the end of treatment
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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).
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From enrollment to 3 months after the end of treatment
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Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26)
Délai: From enrollment to 3 months after the end of treatment
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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
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From enrollment to 3 months after the end of treatment
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Délai: From enrollment to the end of treatment at 6 months
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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
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From enrollment to the end of treatment at 6 months
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Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Délai: From enrollment to 3 months after the end of treatment.
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Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Elevated ALT levels indicate hepatocellular injury (worse outcome).
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From enrollment to 3 months after the end of treatment.
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Renal function was assessed by measuring serum creatinine (SCr) levels
Délai: From enrollment to 3 months after the end of treatment
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Renal function was assessed by measuring serum creatinine (SCr) levels.
Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .
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From enrollment to 3 months after the end of treatment
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Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
Délai: From enrollment to 3 months after the end of treatment
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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) .
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From enrollment to 3 months after the end of treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 octobre 2025
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
30 juin 2028
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2026
Dernière vérification
1 octobre 2025
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025YFC3508004 (Autre subvention/numéro de financement: National Key Research and Development Program of China)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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