Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics

Early Phase 1CompletedNCT06102655

Shi Yun46 enrolled

Overview

1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Ovarian Insufficiency Metabolomics Traditional Chinese Medicine Mechanism Clinical Syndrome

Interventions

Jiajian Guishen FormulationDRUG

Jiajian Guishen Formulation is a formulation of Traditional Chinese Medicine.POI patients will be treat with Jiajian Guishen Formulation for three menstrual cycles; their blood samples are collected before and after treatment.No drug will be used in control group, and their blood samples are collected when join the experiment.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: POI Inclusion Criteria: 1. Patients diagnosed by Western medicine with premature ovarian insufficiency; 2. Patients with Chinese medicine differentiation of kidney deficiency and liver depression; 3. 18 ≤ patients' age ≤ 39 years; 4. Patients who do not use other drugs during treatment; 5. Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan. The above five items must be met to be included in the POI patient group in this study. Healthy subjects inclusion criteria: 1. 18 ≤ Age≤ 39 years old; 2. menstrual regularity; 3. There is no abnormality in sex hormone and AMH examination; 4. Voluntarily participate in this research and sign the informed consent form; 5. Those who match the general information such as age, height, and weight of the patients included in POI. Exclusion Criteria: POI exclusion criteria: 1. Patients with congenital gonadal dysplasia or a family history similar to "early menopause"; 2. POI patients with acquired organic lesions or ovarian surgery; 3. Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months; 4. Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system; 5. Patients who are breastfeeding or pregnant; 6. Patients who are allergic to the drugs used in this study or have a history of previous allergy to traditional Chinese medicines. Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Outcomes

Primary Outcomes

follicle stimulating hormone,FSH

Blood samples are collected before and after treatment.

Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Secondary Outcomes

anti mullerian hormone, AMH

Blood samples are collected before and after treatment.

Time frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Evaluation of the efficacy of Traditional Chinese Medicine symptoms

A sacle score to evalyate the symptoms, results of scores ranges from 0 to 108, higher scores mean more severe condition of POI.The main symptoms include menstrual cycle, menstrual flow reduction. Scoring criteria: ① normal menstrual cycle 0 points, 1-2 weeks ahead or behind the wrong 4 points, 2-3 weeks 8 points, more than 3 weeks 12 points; ② menstrual flow than the previous menstrual flow no change 0 points, menstrual flow reduction ≤ ⅓ 4 points, ⅓ \< menstrual flow reduction ≤ ½ 8 points, menstrual flow reduction \> ½ 12 points. Secondary symptoms included lumbar and knee pain, dizziness and tinnitus, loss of libido, increased urination, hot flashes and night sweats, and lower back and lower limb pain et. According to the degree of aggravation of symptoms, the total score was assigned as 0,2,4,8.

Time frame: before and1 month after the treatment

Improved Kupperman Scale Scoring

A sacle score to evalyate the symptoms, results of scores ranges from 0 to 39, higher scores mean more severe condition of POI.Referring to the domestic modified Kupperman Symptom Scoring Criteria in Chinese Obstetrics and Gynecology, edited by Cao Zeyi, to observe and rate perimenopausal symptoms before and after treatment and to quantify the degree of decline in ovarian function.Entries include hot flashes and sweating, sensory abnormalities, insomnia, anxiety and depression, dizziness, fatigue, muscle and joint pain, headache, palpitations, ankylosis of the skin, sexual discomfort, and urinary irritation, with different coefficients for each entry, and according to the aggravating degree of the symptom, they are divided into 0, 1, 2, and 3 points, and the coefficients corresponding to the scoring of the degree of each item are multiplied by a fixed score of the symptom to add up to the total score.

Data from ClinicalTrials.gov

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