Clinical trial

Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency

Name
2023DZMEC-290
Description
1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways.
Trial arms
Trial start
2023-07-24
Estimated PCD
2024-07-23
Trial end
2024-07-23
Status
Recruiting
Phase
Early phase I
Treatment
Jiajian Guishen Formulation
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.
Arms:
treatment group(Jiajian Guishen Formulation)
Size
40
Primary endpoint
follicle stimulating hormone,FSH
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-04-01

1 organization

1 product

5 indications

Organization
Shi Yun
Indication
Mechanisms