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DJP-11 Herbal Formula for Treating Ovarian Function Decline: A Single-Arm Clinical Trial with External Control

DJP-11 Herbal Formula for Treating Ovarian Function Decline: A Single-Arm Clinical Trial with External Control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001741
Enrollment
Unknown
Registered
2026-07-16
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diminished ovarian reserve

Interventions

Experimental Group:DJP-11 Herbal Formula

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese, Guangzhou
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged between 18 and 45 years; 2. Meeting the Western medical diagnostic criteria for DOR (Diminished Ovarian Reserve); 3. Meeting the TCM (Traditional Chinese Medicine) syndrome differentiation of Kidney Deficiency and Liver Depression Pattern (1) soreness and weakness of the waist and knees; 2) dizziness and tinnitus; 3) nocturia/polyuria at night; 4) decreased libido; 5) emotional depression or irritability; 6) breast distension and pain; 7) chest tightness or lower abdominal pain; dark tongue with thin yellow coating, wiry-thin or deep-wiry pulse. At least one item from 1) to 4) and one item from 5) to 7) as secondary symptoms, combined with tongue and pulse findings for syndrome differentiation); 4. Having no pregnancy intention within the past 6 menstrual cycles; 5. Voluntarily participating and signing the written informed consent form; 6. Willingly accepting all follow-up evaluations required by the treatment protocol.

Exclusion criteria

Exclusion criteria: 1. Those with congenital abnormalities of the reproductive organs, or primary or secondary amenorrhea caused by acquired organic lesions or injuries; 2. Those with severe primary diseases of the cardiovascular, hepatic, renal, and hematopoietic systems, diabetic patients, and psychiatric patients; 3. Those who have undergone bilateral or unilateral oophorectomy; 4. Those with known or suspected breast cancer, known or suspected hormone-dependent precancerous lesions or malignant tumors; 5. Those who have used hormones within the past 2 months; 6. Those with known hypersensitivity to any component of this medication; 7. Those with severe hypertriglyceridemia; 8. Pregnant and lactating women; 9. Subjects whom the investigator deems to have poor compliance, inability to assess efficacy, or incomplete data that may affect efficacy evaluation.

Design outcomes

Primary

MeasureTime frame
Level of baseline follicle-stimulating hormone;Level of baseline anti-Müllerian hormone;

Secondary

MeasureTime frame
Antral Follicle Count; Luteinizing Hormone;estradiol;Traditional Chinese Medicine (TCM) Symptom Score;Evaluation of Menstrual Regulation Therapeutic Effect;

Countries

China

Contacts

Public ContactJie Gao

The First Affiliated Hospital of Guangzhou University of Chinese, Guangzhou

gaojie1769@gzucm.edu.cn13760605046

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026