Bushen Yiqi Formula Combined With Dehydroepiandrosterone in Women With Diminished Ovarian Reserve

NCT07535983 | Recruiting Phase 1

• 1 other identifier: ky20251120005
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can the Bushen Yiqi formula combined with DHEA improve ovarian reserve in women with DOR?
2. 2.Does the combined treatment improve hormone levels, ovarian follicle parameters, and clinical symptoms?
3. 3.What safety issues may occur during treatment with the Bushen Yiqi formula combined with DHEA?
4. 4.Be randomly assigned to either the treatment group or the control group
5. 5.Receive DHEA combined with the Bushen Yiqi formula or DHEA combined with placebo for 12 weeks
6. 6.Undergo regular clinical assessments during the study period
7. 7.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

Conditions

Diminished Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• AMH

  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.

  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.

Study Arms (2)

Therapy group

EXPERIMENTAL

Participants in the therapy group will receive dehydroepiandrosterone (DHEA) combined with the Bushen YiQi formula. DHEA will be administered orally, and the Bushen YiQi formula will be administered according to the study protocol. The treatment duration will be 12 weeks.

Drug: Bushen formula combined with dehydroepiandrosterone

Control group

PLACEBO COMPARATOR

Participants in the control group will receive dehydroepiandrosterone (DHEA) combined with placebo. DHEA will be administered orally, and the placebo will be identical in appearance and administration schedule to the Bushen YiQi formula. The treatment duration will be 12 weeks.

Drug: Placebo combined with dehydroepiandrosterone

Interventions

Placebo combined with dehydroepiandrosterone DRUG

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.

Control group

Bushen formula combined with dehydroepiandrosterone DRUG

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.

Therapy group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who meet both the Western medical diagnostic criteria for DOR and the Traditional Chinese Medicine (TCM) diagnostic criteria.
• Female patients aged 20-40 years (inclusive).
• No use of estrogen or progestin medications within the past three months.
• Voluntary participation in this study, with informed consent provided and a written informed consent form signed.

You may not qualify if:

• Concurrent reproductive endocrine, metabolic, or immune system disorders that could affect ovarian reserve or confound the evaluation of treatment efficacy, including:Polycystic ovary syndrome(PCOS),Hyperprolactinemia (a single elevated prolactin level \> 3 times the upper limit of normal),Poorly controlled thyroid disease (thyroid-stimulating hormone \[TSH\] outside the normal reference range),Addison's disease,Systemic lupus erythematosus (SLE),Crohn's disease,Poorly controlled diabetes mellitus, etc.
• Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy/Chemotherapy,Ovarian hyperstimulation from prior in vitro fertilization (IVF) cycles
• Any of the following untreated or severe gynecological conditions:Unexplained irregular vaginal bleeding、Adnexal mass with a single largest diameter ≥ 4 cm、Stage III-IV endometriosis or bilateral ovarian endometriomas、Uterine fibroid(s) with a single largest diameter ≥ 4 cm、Endometrial polyp(s) with a single largest diameter \> 1.5 cm、Planned pelvic surgery during the trial period
• Reduced menstrual flow (oligomenorrhea/hypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the reproductive organs、Prior intrauterine procedures
• Patients with severe diseases of the cardiovascular or cerebrovascular system, liver, kidney, hematopoietic system, or other major organ systems, as well as those with psychiatric disorders or intellectual disabilities.
• Pregnancy or lactation.
• Known allergy or hypersensitivity to any component of the investigational drugs in this study.
• Participation in any other clinical trial within the 3 months preceding randomization.
• Unwillingness to sign the informed consent form for this study.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Central Study Contacts

Ruining Liang

CONTACT

0086-0791-88385243; xuling1108@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: April 17, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)