Study Comparing Bushen Yiqi Herbal Formula Plus DHEA to DHEA with Placebo for Treating Ovarian Function Decline in Women

What this Trial Is About

Researchers are evaluating the efficacy and safety of the Bushen Yiqi formula combined with dehydroepiandrosterone DHEA in treating women with diminished ovarian reserve DOR. This study aims to determine whether this combined therapy can improve ovarian reserve, hormone levels, ovarian follicle characteristics, and clinical symptoms, while also assessing potential safety concerns. The trial compares the combined treatment to DHEA plus a placebo to see if the combination offers better results. Participants will be randomly assigned to one of two groups one receiving DHEA combined with the Bushen Yiqi formula and the other receiving DHEA with a placebo. Both treatments are given orally for 12 weeks. The Bushen Yiqi formula is a granulated herbal mixture taken twice daily, while DHEA tablets are taken three times daily. The placebo is designed to look and taste like the herbal formula to maintain blinding. During the study, participants will undergo regular clinical assessments including measurement of ovarian reserve markers like AMH and antral follicle count, sex hormone levels FSH, LH, E2, testosterone, traditional Chinese medicine symptom scores, menopausal index scores, inflammatory markers CRP and IL-6, and safety evaluations. Blood samples for AMH will be collected at specific menstrual cycle days before treatment, after treatment, and after a 3-month follow-up. The total participation period includes treatment and follow-up assessments to monitor outcomes and safety.

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