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The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea

5. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

210

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Yan Deng, Doctor
  • Telefonnummer: 86+010-69158331
  • E-mail: yanndeng@163.com

Studiesteder

  • Kina
      • Beijing, Kina, 100730
        • Rekruttering
        • Peking Union Medical College Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Aijun Sun, Doctor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Diagnostic criteria for functional hypothalamic amenorrhea

  1. primary or secondary amenorrhea
  2. Normal or low FSH levels, LH < 5 IU/L, E2 < 50 pg/mL
  3. 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:

  1. Individuals who have used relevant medications within the past 3 months
  2. History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
  3. Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients
  4. Lactating or pregnant women, or females within one year postpartum
  5. History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
  6. Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
  7. History of thromboembolic disease or thrombotic tendency.
  8. Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Femoston group
Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.
Medicin: Western medicine
Western medicine（Femoston 2/10)
Eksperimentel: 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.
Medicin: traditional Chinese medicine
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
Eksperimentel: 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.
Medicin: Western medicine
Western medicine（Femoston 2/10)
Medicin: traditional Chinese medicine
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Menstrual patterns during treatment and after discontinuation
Tidsramme: 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
Sex hormone levels
Tidsramme: 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).
from enrollment to the end of treatment at 6 months
Uterine volume
Tidsramme: 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.
From enrollment to the end of treatment at 6 months
Quality of Life Score(36-Item Short Form Health Survey，SF 36)
Tidsramme: 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.
From enrollment to the end of treatment at 6 months
Total ovarian volume
Tidsramme: from enrollment to the end of treatment at 6 months
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.
from enrollment to the end of treatment at 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Tidsramme: 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.
Tidsramme: 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).
From enrollment to 3 months after the end of treatment
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
Tidsramme: 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)
Tidsramme: 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
From enrollment to 3 months after the end of treatment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tidsramme: 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
From enrollment to the end of treatment at 6 months
Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Tidsramme: 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).
From enrollment to 3 months after the end of treatment.
Renal function was assessed by measuring serum creatinine (SCr) levels
Tidsramme: 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) .
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) .
Tidsramme: 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) .
From enrollment to 3 months after the end of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Samarbejdspartnere

Guangdong Provincial Hospital of Traditional Chinese Medicine
Peking University Third Hospital
Beijing University of Chinese Medicine
Dongfang Hospital Beijing University of Chinese Medicine
Beijing University of Chinese Medicine Third Affiliated Hospital
Shenyang Women's and Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. oktober 2025

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. oktober 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025YFC3508004 (Andet bevillings-/finansieringsnummer: National Key Research and Development Program of China)

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