A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline

The purpose of this clinical trial is to evaluate the efficacy and safety of Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in the treatment of women with diminished ovarian reserve (DOR). The study also aims to assess the safety profile of this combined therapy. The main questions this study aims to answer include: 1. Can the Bushen Yiqi formula combined with DHEA improve ovarian reserve in women with DOR? 2. Does the combined treatment improve hormone levels, ovarian follicle parameters, and clinical symptoms? 3. What safety issues may occur during treatment with the Bushen Yiqi formula combined with DHEA? Researchers will compare the Bushen Yiqi formula combined with DHEA to DHEA plus placebo to determine whether the combined therapy is more effective in treating diminished ovarian reserve. Participants will: 1. Be randomly assigned to either the treatment group or the control group 2. Receive DHEA combined with the Bushen Yiqi formula or DHEA combined with placebo for 12 weeks 3. Undergo regular clinical assessments during the study period 4. Have ovarian reserve markers (including AMH and antral follicle count), sex hormone levels (FSH, LH, E2, and testosterone), traditional Chinese medicine symptom scores, Kupperman menopausal index scores, inflammatory markers (CRP and IL-6), and safety indicators evaluated before and after treatment

NCT Number	NCT07535983
Lead Sponsor	Jiangxi University of Traditional Chinese Medicine
Conditions	Diminished Ovarian Reserve
Enrollment	74 participants
Start Date	2025-09-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-03