Diminished Ovarian Reserve (DOR)Early Phase 1NCT07841548
Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial
A Early Phase 1 study testing Guishen Yijing Granules and Coenzyme Q10 (drug) in people with Diminished Ovarian Reserve (DOR), run by Shi Yun.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- Guishen Yijing Granules and Coenzyme Q10 (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2026to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 informed consent after being fully informed of the study details.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaoying Li, Master contact
About this study
Official title: A Randomized and Double-blind Clinical Trial of Guishen Yijing Granules on the Modulation of Ovarian Function in Patients With Diminished Ovarian Reserve
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.
Read more
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.
Read the detailed description
This study was a multicenter, stratified block randomized, double-blind, double simulation clinical trial.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- Guishen Yijing Granules, Coenzyme Q10 (drug)
- Keywords
- Diminished Ovarian Reserve, Ovarian function, Guishen Yijing Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guishen Yijing GranulesDrug
Also called 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
Coenzyme Q10 (drug)Drug
Also called CoQ10
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
| Study group | Role | What they receive |
|---|---|---|
| Guishen Yijing Granules Group | Experimental | Guishen Yijing Granules Receives: Drug: Guishen Yijing Granules |
| coenzyme Q10 group | Active comparator | coenzyme Q10 Receives: Drug: Coenzyme Q10 (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before treatment and the first menstrual period 2-4 days after treatment
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before treatment and on days 2-4 of the early follicular phase in the first post-treatment menstrual cycle
Traditional Chinese Medicine Score
Measured: baseline and immediately after treatment
Modified Kupperman rating scale
Measured: baseline and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start22 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Stratified Block Group Randomized Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yun, Dongzhimen Hospital, Beijing
- Investigators
- Yun Shi, phD, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese MedicinePiwen Zhao, Principal investigator, Beijing University of Chinese MedicineQiaohui Yang, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese MedicineChunmei Wang, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese MedicineXiaoxia Bao, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese MedicineQingya Yan, Principal investigator, DHaiyunongzhimen Hospital of Beijing University of Chinese MedicineHaiyun Sun, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841548
- Sponsor's protocol ID
- 2025DZMEC-493
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Double-blind Clinical Trial of Guishen Yijing Granules on the Modulation of Ovarian Function in Patients With Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT07841548
- Acronym / sponsor ID
- 2025DZMEC-493
- Conditions
- Diminished Ovarian Reserve (DOR)
- Keywords
- Diminished Ovarian Reserve, Ovarian function, Guishen Yijing Granules
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shi YunUniversity, hospital or other
- Study start
- 22 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a multicenter, stratified block randomized, double-blind, double simulation clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Stratified Block Group Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Guishen Yijing Granules Group | Experimental | Drug: Guishen Yijing GranulesGuishen Yijing Granules |
| coenzyme Q10 group | Active comparator | Drug: Coenzyme Q10 (drug)coenzyme Q10 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 informed consent after being fully informed of the study details.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guishen Yijing GranulesAlso: GSYJThis 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 | Drug | Guishen Yijing Granules Group |
| Coenzyme Q10 (drug)Also: CoQ10This 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 | Drug | coenzyme Q10 group |
Primary outcome
Anti-Miller's Tube Hormone（AMH）
Time frame: before treatment and the first menstrual period 2-4 days after treatment
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
8 secondary outcomes
Follicle-stimulating hormone（FSH）
Time frame: before treatment and the first menstrual period 2-4 days after treatment
Luteinizing hormone（LH）
Time frame: before treatment and the first menstrual period 2-4 days after treatment
Estrogen (E2)
Time frame: before treatment and the first menstrual period 2-4 days after treatment
Progesterone (P)
Time frame: before treatment and the first menstrual period 2-4 days after treatment
Testosterone（T）
Time frame: before treatment and the first menstrual period 2-4 days after treatment
antral follicle count（AFC）
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoying Li, Master contact
Yun Shi, phD principal investigator
Dongzhimen Hospital of Beijing University of Chinese Medicine
Piwen Zhao principal investigator
Beijing University of Chinese Medicine
Qiaohui Yang principal investigator
Dongzhimen Hospital of Beijing University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Guishen Yijing Granules and Coenzyme Q10 (drug) in people with Diminished Ovarian Reserve (DOR), run by Shi Yun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Shi, phD (13717926522, zhyshiyun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Miller's Tube Hormone（AMH） (time frame: before treatment and the first menstrual period 2-4 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.