Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Bu Shen Yi Qi Formula With Chinese Herbal Placebo Combined With Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Dysfunction
Led by Jiangxi University of Traditional Chinese Medicine · Updated on 2026-06-03
74
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who meet both the Western medical diagnostic criteria for diminished ovarian reserve and the Traditional Chinese Medicine diagnostic criteria
- Female patients aged 20 to 40 years inclusive
- No use of estrogen or progestin medications within the past three months
- Voluntary participation with informed consent provided and a signed consent form
You will not qualify if you...
- Having reproductive endocrine, metabolic, or immune disorders affecting ovarian reserve or treatment evaluation, such as PCOS, hyperprolactinemia, poorly controlled thyroid disease, Addison's disease, systemic lupus erythematosus, Crohn's disease, or poorly controlled diabetes
- Diminished ovarian reserve caused by tumor treatments, surgery, radiotherapy, chemotherapy, or ovarian hyperstimulation from prior IVF cycles
- Untreated or severe gynecological conditions including unexplained irregular vaginal bleeding, adnexal mass ≥4 cm, stage III-IV endometriosis or bilateral ovarian endometriomas, uterine fibroids ≥4 cm, endometrial polyps >1.5 cm, or planned pelvic surgery during the trial
- Reduced menstrual flow due to congenital uterine malformations, uterine hypoplasia, organic reproductive organ diseases, or prior intrauterine procedures
- Severe cardiovascular, cerebrovascular, liver, kidney, hematopoietic, or major organ diseases, psychiatric disorders, or intellectual disabilities
- Pregnancy or breastfeeding
- Known allergy or hypersensitivity to any study drug components
- Participation in another clinical trial within 3 months before randomization
- Unwillingness to sign the informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive oral dehydroepiandrosterone (DHEA) tablets three times daily combined with either the Bushen YiQi herbal formula or a matching placebo, taken twice daily.
1 baseline visit and 2 follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
R
Ruining Liang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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