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

Condition(s) studied

Investigational drug(s) / intervention(s)

Bushen formula combined with dehydroepiandrosterone: Patients in the treatment group received the Bushen Yiqi Formula (composed of Rehmanniae Radix Praeparata (Shu Di Huang), Rehmanniae Radix (Sheng Di Huang), Glehniae Radix (Bei Sha Shen), Ophiopogonis Radix (Mai Dong), Asini Corii Colla (E Jiao), Dioscoreae Rhizoma (Shan Yao), Testudinis Carapax et Plastrum (Gui Ban), Cuscutae Semen (Tu Si Zi), Morindae Officinalis Radix (Ba Ji Tian), etc.). The herbal formula was provided as a fine granule for oral administration.Herbal Formula: Starting from the first day of inclusion, subjects took the granulated herbs dissolved in hot water, twice daily, with 2 sachets per dose. The treatment course lasted for 12 weeks.All participants (in both the treatment and control groups) concurrently took dehydroepiandrosterone (DHEA) tablets (25 mg per tablet; Fosun Pharma, USA) at a dosage of 25 mg three times daily.

Placebo combined with dehydroepiandrosterone: The control group received matching placebo preparations. To ensure blinding, both the herbal formula for the treatment group and the placebo for the control group were identically packaged, with indistinguishable appearance, odor, and color.All participants (in both the treatment and control groups) concurrently took dehydroepiandrosterone (DHEA) tablets (25 mg per tablet; Fosun Pharma, USA) at a dosage of 25 mg three times daily.

Study summary

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

Eligibility

Primary outcome measure(s)

• AMH — Blood samples were collected on days 2-4 of the menstrual cycle at three predefined time points: (1) baseline, (2) the first menstrual cycle after treatment, and (3) the first menstrual cycle following the 3-month follow-up period.
  Serum anti-Müllerian hormone (AMH) levels will be measured to assess ovarian reserve function. Changes in AMH levels from baseline to post-treatment and follow-up will be compared between the treatment group and the control group.

Trial sites (1)

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