Actively Recruiting

Phase 4
Age: 14Years - 40Years
FEMALE
NCT07580950

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

Led by Peking Union Medical College Hospital · Updated on 2026-05-12

210

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

P

Peking Union Medical College Hospital

Lead Sponsor

P

Peking University Third Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with functional hypothalamic amenorrhea
  • Primary or secondary amenorrhea
  • Normal or low FSH levels, LH less than 5 IU/L, E2 less than 50 pg/mL
  • Amenorrhea not caused by organic hypothalamus or pituitary lesions, ovarian amenorrhea, uterine or genital tract abnormalities, drug-induced amenorrhea, or other causes
Not Eligible

You will not qualify if you...

  • Use of relevant medications within the past 3 months
  • History of substance abuse or dependence (alcohol or drugs) within past 3 months
  • Heavy smoking (20 or more cigarettes daily)
  • Severe or unstable physical illnesses including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or blood disorders
  • Psychiatric illness
  • Lactating or pregnant women, or females within one year postpartum
  • Allergy to study drugs or contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
  • Estrogen-sensitive tumors such as endometrial or breast cancer
  • History of blood clots or thrombotic tendency
  • Participation in another investigational drug trial within 1 month before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China, 100730

Actively Recruiting

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Research Team

Y

Yan Deng, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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