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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Hypothalamic Amenorrhea
• Intervention / Treatment: Drug: Western medicine; Drug: traditional Chinese medicine

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yan Deng, Doctor; Phone Number: 86+010-69158331; Email: yanndeng@163.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Yan Deng, Doctor; Phone Number: 01069158331; Email: yanndeng@163.com
    • Principal Investigator: Aijun Sun, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoston group; Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.	Drug: Western medicine; Western medicine（Femoston 2/10)
Experimental: 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.	Drug: traditional Chinese medicine; traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
Experimental: 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.	Drug: Western medicine; Western medicine（Femoston 2/10); Drug: traditional Chinese medicine; traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)	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.	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)	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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.	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	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) .	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Functional Hypothalamic Amenorrhea; Integrated Traditional Chinese and Western Clinical Medicine
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Medicine, East Asian Traditional; Medicine, Traditional; Medicine, Chinese Traditional
• Other Study ID Numbers: 2025YFC3508004 (Other Grant/Funding Number: National Key Research and Development Program of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No