The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
5 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
210
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yan Deng, Doctor
- Telefonnummer: 86+010-69158331
- E-post: yanndeng@163.com
Studieorter
-
-
-
Beijing, Kina, 100730
- Rekrytering
- Peking Union Medical College Hospital
-
Kontakt:
- Yan Deng, Doctor
- Telefonnummer: 01069158331
- E-post: yanndeng@163.com
-
Huvudutredare:
- Aijun Sun, Doctor
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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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Experimentell: 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.
|
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
|
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Experimentell: 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.
|
Western medicine（Femoston 2/10)
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Menstrual patterns during treatment and after discontinuation
Tidsram: 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
|
From enrollment, during the treatment of 6 months, and within 3 months after treatment
|
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Sex hormone levels
Tidsram: 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).
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from enrollment to the end of treatment at 6 months
|
|
Uterine volume
Tidsram: 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)
Tidsram: 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.
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From enrollment to the end of treatment at 6 months
|
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Total ovarian volume
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Tidsram: 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).
|
From enrollment to 3 months after the end of treatment
|
|
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Tidsram: 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).
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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)
Tidsram: 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).
|
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)
Tidsram: 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
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From enrollment to 3 months after the end of treatment
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tidsram: From enrollment to the end of treatment at 6 months
|
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.
Tidsram: From enrollment to 3 months after the end of treatment.
|
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.
|
|
Renal function was assessed by measuring serum creatinine (SCr) levels
Tidsram: From enrollment to 3 months after the end of treatment
|
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) .
Tidsram: 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) .
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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Samarbetspartners och utredare
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Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 oktober 2025
Primärt slutförande (Beräknad)
30 juni 2028
Avslutad studie (Beräknad)
30 juni 2028
Studieregistreringsdatum
Först inskickad
27 april 2026
Först inskickad som uppfyllde QC-kriterierna
5 maj 2026
Första postat (Faktisk)
12 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2026
Senast verifierad
1 oktober 2025
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025YFC3508004 (Annat bidrag/finansieringsnummer: National Key Research and Development Program of China)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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