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

Phase 4RecruitingNCT07580950

Peking Union Medical College Hospital210 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Functional Hypothalamic Amenorrhea

Interventions

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 40 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Menstrual patterns during treatment and after discontinuation

Document the number of episodes of menstruation during the treatment and follow-up period

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: from enrollment to the end of treatment at 6 months

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: From enrollment to 3 months after the end of treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts