Status:
COMPLETED
Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics
Lead Sponsor:
Shi Yun
Conditions:
Premature Ovarian Insufficiency
Metabolomics
Eligibility:
FEMALE
18-39 years
Phase:
EARLY_PHASE1
Brief Summary
1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways.
Eligibility Criteria
Inclusion
- POI
- Patients diagnosed by Western medicine with premature ovarian insufficiency;
- Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
- 18 ≤ patients' age ≤ 39 years;
- Patients who do not use other drugs during treatment;
- 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:
- 18 ≤ Age≤ 39 years old;
- menstrual regularity;
- There is no abnormality in sex hormone and AMH examination;
- Voluntarily participate in this research and sign the informed consent form;
- Those who match the general information such as age, height, and weight of the patients included in POI.
Exclusion
- POI exclusion criteria:
- Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
- POI patients with acquired organic lesions or ovarian surgery;
- Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
- Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
- Patients who are breastfeeding or pregnant;
- 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).
Key Trial Info
Start Date :
July 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06102655
Start Date
July 24 2023
End Date
July 20 2024
Last Update
December 5 2024
Active Locations (1)
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1
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, China