NCT07580950

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
26mo left

Started Oct 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Oct 2025Jun 2028

Study Start

First participant enrolled

October 22, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 12, 2026

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

April 27, 2026

Last Update Submit

May 5, 2026

Conditions

Functional Hypothalamic Amenorrhea

Keywords

Functional Hypothalamic AmenorrheaIntegrated Traditional Chinese and Western Clinical MedicineRandomized controlled trial

Outcome Measures

Primary Outcomes (5)

  • 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-Müllerian 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 × 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)

    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 (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

Secondary Outcomes (4)

  • Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)

    From enrollment to 3 months after the end of treatment

  • Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.

    From enrollment to 3 months after the end of treatment

  • Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)

    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)

    From enrollment to 3 months after the end of treatment

Other Outcomes (4)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    From enrollment to the end of treatment at 6 months

  • Serum alanine aminotransferase (ALT) levels were measured to assess liver function.

    From enrollment to 3 months after the end of treatment.

  • Renal function was assessed by measuring serum creatinine (SCr) levels

    From enrollment to 3 months after the end of treatment

  • +1 more other outcomes

Study Arms (3)

Femoston group

ACTIVE COMPARATOR

Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.

Drug: Western medicine

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.

Drug: traditional Chinese medicine

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.

Drug: traditional Chinese medicineDrug: Western medicine

Interventions

traditional Chinese medicineDRUG

traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）

Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston groupBa Zhen Yi Mu Pill and Ding Kun Dan group
Western medicineDRUG

Western medicine（Femoston 2/10)

Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston groupFemoston group

Eligibility Criteria

Age14 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnostic criteria for functional hypothalamic amenorrhea
  • primary or secondary amenorrhea
  • Normal or low FSH levels, LH \< 5 IU/L, E2 \< 50 pg/mL

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Interventions

Medicine, Chinese Traditional

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Central Study Contacts

Yan Deng, Doctor

CONTACT

86+010-69158331yanndeng@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 12, 2026

Study Start

October 22, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

May 12, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)