An Early Phase 1 interventional study of Guishen Yijing Granules and Coenzyme Q10 (drug) in Diminished Ovarian Reserve (DOR), sponsored by Shi Yun. Not yet recruiting. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Shi Yun · Early Phase 1, Interventional, and Treatment
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.
This study was a multicenter, stratified block randomized, double-blind, double simulation clinical trial.
Shi Yun is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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(1) fulfillment of the diagnostic criteria for diminished ovarian reserve; (2) fulfillment of the Traditional Chinese Medicine pattern differentiation criteria for kidney deficiency syndrome; (3) age between 25 and 45 years (25 ≤ age \< 45); (4) baseline follicle-stimulating hormone level between 10 and 25 IU/L (10 IU/L ≤ baseline FSH \< 25 IU/L); and (5) voluntary provision of written after being fully informed of the study details.
Exclusion Criteria:
(1) pregnancy or lactation; (2) comorbidities involving severe conditions of the cardiovascular, cerebrovascular, or hematopoietic systems, or malignant tumors; (3) primary amenorrhea or a family history of early menopause; (4) diminished ovarian reserve caused by ovarian or related surgery; (5) mental disorders or intellectual disability; (6) use of hormonal medications within the past 3 months; or (7) concurrent participation in other clinical trials.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Guishen Yijing Granules
Drug: Guishen Yijing Granules
coenzyme Q10
Drug: Coenzyme Q10 (drug)
This 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
Also known as: GSYJ
This 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
Also known as: CoQ10
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
Time frame: before treatment and the first menstrual period 2-4 days after treatment
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.
Time frame: before treatment and the first menstrual period 2-4 days after treatment
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.
Time frame: before treatment and the first menstrual period 2-4 days after treatment
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.
Time frame: before treatment and the first menstrual period 2-4 days after treatment
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.
Time frame: before treatment and the first menstrual period 2-4 days after treatment
Testosterone（T）
The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, T were measured by radioimmunoassay.
Time frame: before treatment and the first menstrual period 2-4 days after treatment
antral follicle count（AFC）
Color Doppler ultrasound was performed in the early follicular phase in the usual way to observe the number of follicles in the underlying sinuses.
Time frame: before treatment and on days 2-4 of the early follicular phase in the first post-treatment menstrual cycle
Traditional Chinese Medicine Score
Time frame: baseline and immediately after treatment
Modified Kupperman rating scale
Time frame: baseline and immediately after treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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