Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial

NCT07841548 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2025DZMEC-493
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Diminished Ovarian Reserve (DOR)

Keywords

Diminished Ovarian Reserve; Ovarian function; Guishen Yijing Granules

Outcome Measures

Primary Outcomes (1)

• 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

  before treatment and the first menstrual period 2-4 days after treatment

Secondary Outcomes (8)

• Follicle-stimulating hormone（FSH）

  before treatment and the first menstrual period 2-4 days after treatment

• Luteinizing hormone（LH）

  before treatment and the first menstrual period 2-4 days after treatment

• Estrogen (E2)

  before treatment and the first menstrual period 2-4 days after treatment

• Progesterone (P)

  before treatment and the first menstrual period 2-4 days after treatment

• Testosterone（T）

  before treatment and the first menstrual period 2-4 days after treatment

Study Arms (2)

Guishen Yijing Granules Group

EXPERIMENTAL

Guishen Yijing Granules

Drug: Guishen Yijing Granules

coenzyme Q10 group

ACTIVE COMPARATOR

coenzyme Q10

Drug: Coenzyme Q10 (drug)

Interventions

Guishen Yijing Granules 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

Guishen Yijing Granules Group

Coenzyme Q10 (drug) 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: CoQ10

coenzyme Q10 group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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 informed consent after being fully informed of the study details.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shi Yun: lead

MeSH Terms

Interventions

coenzyme Q10; Pharmaceutical Preparations

Study Officials

• Yun Shi, phD

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Piwen Zhao

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Qiaohui Yang

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Chunmei Wang

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Xiaoxia Bao

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Qingya Yan

  DHaiyunongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Haiyun Sun

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Shi, phD

CONTACT

13717926522; zhyshiyun@126.com

Xiaoying Li, Master

CONTACT

lixiaoying64@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Gynecology

Model Details: A Stratified Block Group Randomized Controlled Study

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: September 22, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share