Clinical trial NCT06102655: Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics
Official title: Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Premature Ovarian Insufficiency
Metabolomics
Traditional Chinese Medicine
Mechanism
Clinical Syndrome
Keywords: Premature Ovarian Insufficiency
Metabolomics
Traditional Chinese Medicine
Mechanism
Clinical Syndrome
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: follicle stimulating hormone,FSH
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Secondary outcomes:
measure: anti mullerian hormone, AMH
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: Evaluation of the efficacy of Traditional Chinese Medicine symptoms
timeFrame: before and1 month after the treatment
measure: Improved Kupperman Scale Scoring
timeFrame: before and 1 month after the treatment
measure: estradiol, E2
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: luteinizing hormone, LH
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: testosterone, T
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: malondialdehyde
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: superoxide dismutase
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: reduced glutathione, GSH
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: ceruloplasmin
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: copper
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: metabolite level
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: Differential metabolites and their related indexes of mechanism pathways
timeFrame: Differential metabolites will be tested on the 2~4th day of menstruation (amenorrhea patients before and after taking medication), related indexes of mechanism pathways will be tested after the analyses of differential metabolities
measure: Number of participants with abnormal laboratory test of blood routine examination results
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
measure: Number of participants with abnormal Liver and kidney function (by laboratory test results)
timeFrame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese Medicine
Study officials:
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Yun Shi
role: STUDY_DIRECTOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Ke Xu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Jing yi Shao, Master
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Xi yu Li, Bachelor
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Qin yang Liu, Bachelor
role: STUDY_CHAIR
References: