This study is a multicenter, stratified block-randomized, double-blind, double-dummy clinical trial designed to evaluate the efficacy and safety of Guishen Yijing Granules in patients with diminished ovarian reserve (DOR) and kidney deficiency syndrome through multidimensional assessment of clinical outcomes before and after treatment.
A total of 120 patients with DOR will be recruited from the gynecology outpatient departments of Dongzhimen Hospital, Beijing University of Chinese Medicine; Xiyuan Hospital, China Academy of Chinese Medical Sciences; and Beijing Chaoyang Hospital, Capital Medical University. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group, with 60 participants in each group.
Participants in the experimental group will receive Guishen Yijing Granules plus a coenzyme Q10 placebo, whereas those in the control group will receive coenzyme Q10 plus a Guishen Yijing Granules placebo. Treatment will begin on day 5 of the menstrual cycle. For participants with amenorrhea, treatment will begin after pregnancy has been excluded. Each treatment cycle will consist of 21 consecutive days of medication. If menstruation occurs after completion of a treatment cycle, the next treatment cycle will begin on day 5 of the subsequent menstrual cycle. If menstruation does not occur, participants will discontinue treatment for 7 days after pregnancy has been excluded and then begin the next treatment cycle according to the same regimen. Treatment will continue for three menstrual cycles; participants with amenorrhea will receive treatment for 3 months.
Outcomes assessed before and after treatment will include basal serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels, anti-Müllerian hormone (AMH), antral follicle count (AFC), traditional Chinese medicine syndrome scores, and modified Kupperman Index scores. The study aims to evaluate the efficacy and safety of Guishen Yijing Granules and their effects on ovarian function in patients with DOR.
None
None
Parallel
Guishen Yijing Granules
DrugThis study was a stratified district group randomized, double-blind, double simulation clinical trial with GSYJ granules + coenzyme Q10 simulant in the test group and GSYJ granules simulant + coenzyme Q10 in the control group
Coenzyme Q10 (drug)
DrugThis study was a stratified district group randomized, double-blind, double simulation clinical trial with GSYJ granules + coenzyme Q10 simulant in the test group and GSYJ granules simulant + coenzyme Q10 in the control group
Anti-Miller's Tube Hormone（AMH）
The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, anti-mullerian hormone (AMH) was measured by radioimmunoassay
Follicle-stimulating hormone（FSH）
The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, FSH were measured by radioimmunoassay.
Luteinizing hormone（LH）
The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, LH were measured by radioimmunoassay.
Estrogen (E2)
The unit is pg/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, E2 were measured by radioimmunoassay.
Progesterone (P)
The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, P were measured by radioimmunoassay.
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Shi Yun
Lead sponsor
Dongzhimen Hospital, Beijing
Sponsor institution
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