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Clinical observation of Zikui Tiaogan decoction in the treatment of diminished ovarian reserve:protocol for a randomized, controlled, noninferiority trial

Clinical observation of Zikui Tiaogan decoction in the treatment of diminished ovarian reserve:protocol for a randomized, controlled, noninferiority trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076694
Enrollment
Unknown
Registered
2023-10-16
Start date
2023-11-30
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Diminished ovarian reserve

Interventions

Treatment group:Zikui Tiaogan decoction plus fenmatong simulator
Control group:Fenmatong plus Zikui Tiaogan decoction simulator

Sponsors

Dongguan Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Conforming to the diagnostic criteria of Western medicine for decreased ovarian reserve function and traditional Chinese medicine for liver depression and kidney deficiency syndrome; (2) Between the ages of 18 and 40; (3) Have not used hormone drugs within the past 3 months; (4) The patient voluntarily participated in this clinical observation, signed relevant informed consent forms, and was able to cooperate in completing the clinical observation.

Exclusion criteria

Exclusion criteria: (1) Breastfeeding women and pregnant women; (2) Allergic to the experimental Drug allergy (allergic to known ingredients or more than two drugs); (3) Surgery, radiation therapy, and chemotherapy lead to a decrease in ovarian reserve function; (4) History of Endocrine disease such as hyperprolactinemia and polycystic ovary syndrome; (5) Patients who have received sex hormone drugs and other Endocrine disease in the past three months; (6) Concomitant severe liver, kidney, and circulatory system diseases and mental disorders; (7) Not being able to use drugs or other medications to treat diseases according to regulations, which affects the effectiveness of judgment; (8) Receiving treatment for other diseases or participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
FSH;

Secondary

MeasureTime frame
AMH;E2;LH;AFC;OV;

Countries

China

Contacts

Public ContactLi Zhao

Dongguan Maternal and Child Health Care Hospital

778774975@qq.com+86 139 2552 3388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026