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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age14-40
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary or secondary amenorrhea

Normal or low FSH levels, LH < 5 IU/L, E2 < 50 pg/mL

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • traditional Chinese medicine

    Drug

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

  • Western medicine

    Drug

    Western medicine(Femoston 2/10)

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Femoston groupActive comparator 1 intervention
Group B: Ba Zhen Yi Mu Pill and Ding Kun Dan groupExperimental treatment 1 intervention
Group C: Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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

Time frame
From enrollment to the end of treatment at 6 months
2

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).

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

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) .

Time frame
From enrollment to 3 months after the end of treatment
4

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) .

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

Sponsors and contacts

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Peking Union Medical College Hospital

Lead sponsor

Peking University Third Hospital

Collaborator

Dongfang Hospital Beijing University of Chinese Medicine

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

Shenyang Women's and Children's Hospital

Collaborator

Beijing University of Chinese Medicine Third Affiliated Hospital

Collaborator

Beijing University of Chinese Medicine

Collaborator