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

June 1, 2026 updated by: Ruining Liang, Jiangxi University of Traditional Chinese Medicine

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy/Chemotherapy,Ovarian hyperstimulation from prior in vitro fertilization (IVF) cycles
  3. 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
  4. Reduced menstrual flow (oligomenorrhea/hypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the reproductive organs、Prior intrauterine procedures
  5. 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.
  6. Pregnancy or lactation.
  7. Known allergy or hypersensitivity to any component of the investigational drugs in this study.
  8. Participation in any other clinical trial within the 3 months preceding randomization.
  9. Unwillingness to sign the informed consent form for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy group
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
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 Comparator: Control group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ky20251120005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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