The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Yan Deng, Doctor
- Puhelinnumero: 86+010-69158331
- Sähköposti: yanndeng@163.com
Opiskelupaikat
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Beijing, Kiina, 100730
- Rekrytointi
- Peking Union Medical College Hospital
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Ottaa yhteyttä:
- Yan Deng, Doctor
- Puhelinnumero: 01069158331
- Sähköposti: yanndeng@163.com
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Päätutkija:
- Aijun Sun, Doctor
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Active Comparator: 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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Kokeellinen: 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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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Menstrual patterns during treatment and after discontinuation
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: From enrollment to the end of treatment at 6 months
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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)
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Aikaikkuna: 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.
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Muut tulostoimenpiteet
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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) .
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Yhteistyökumppanit
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 2025YFC3508004 (Muu apuraha/rahoitusnumero: National Key Research and Development Program of China)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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