Ovarian dysfunction
Conditions
Interventions
Treatment group:The treatment group received the Kidney-Tonic and Qi-Supplementing Formula (comprising Rehmannia glutinosa (Shu Di), Fresh Rehmannia (Sheng Di), Northern Sand (Bei Sha Shen), Ophiopogo
Control Group:The control group received placebo treatment, and both the treatment group and the control group were administered uniformly packaged medication, identical in appearance, odor, and color
Sponsors
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Participants who meet both the Western medical diagnostic criteria and the Chinese medical diagnostic criteria for DOR; 2. Female patients aged 20 = age < 40 years; 3. Participants who have not taken estrogen or progestogen medications in the past three months; 4. Participants who voluntarily participate in this study, have been informed of the study details, and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other conditions affecting ovarian reserve function or the evaluation of drug efficacy, such as polycystic ovary syndrome, hyperprolactinemia (PRL levels significantly higher than normal, i.e., more than three times the upper limit of normal, which can be confirmed by a single test), uncontrolled thyroid disease (TSH not within the normal reference range), Addison's disease, systemic lupus erythematosus, Crohn's disease, uncontrolled diabetes, etc. 2. Diminished ovarian reserve caused by iatrogenic factors such as tumors, surgery, radiotherapy/chemotherapy, or ovarian stimulation for in vitro fertilization. 3. Unexplained irregular vaginal bleeding that has not been cured; adnexal mass with a single maximum diameter =4 cm; endometriosis at stage III-IV, bilateral ovarian endometriotic cysts; uterine fibroids with a single maximum diameter =4 cm; endometrial polyps with a single maximum diameter >1.5 cm; expected pelvic surgery during the study period. 4. Menorrhagia caused by uterine congenital malformations, underdevelopment, organic lesions of the reproductive organs, or intrauterine manipulative procedures. 5. Severe diseases of the cardiovascular, liver, kidney, hematopoietic system, or other systems; mental illness or intellectual disabilities. 6. Pregnant or breastfeeding women. 7. Allergy to the study drug or its components. 8. Participation in other clinical trials within the past three months prior to randomization. 9. Unwillingness to sign the informed consent form for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-Müllerian Hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex Hormone Levels;Antral Follicle Count (AFC);FertiQoL Scale;TCM Syndrome Score;Modified Kupperman Scale;Interleukin-6;High-sensitivity C-reactive protein;Pregnancy rate; | — |
Countries
China
Contacts
Public ContactRuining Liang
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Outcome results
None listed