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Research on the Clinical Optimization Scheme and Mechanism of Ningxin Tongyu Zishen Formula for POI Based on the Principle of Simultaneous Treatment of Heart and Kidney.

Research on the Clinical Optimization Scheme and Mechanism of Ningxin Tongyu Zishen Formula for POI Based on the Principle of Simultaneous Treatment of Heart and Kidney.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000521
Enrollment
Unknown
Registered
2025-03-13
Start date
2022-06-08
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Premature Ovarian Insufficiency

Interventions

Western medicine treatment group:estrogen-progesterone sequential therapy
western medicine and Chinese medicine combined treatment group:Ningxin Tongyu Zishen Formula combined with estrogen-progesterone sequential therapy
Chinese medicine treatment group:Ningxin Tongyu Zishen Formula

Sponsors

The 3rd Affiliated Hospital Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: (1) Female patients aged 18 to under 40 years; (2) Meet the diagnostic criteria for Primary Ovarian Insufficiency (POI): female patients under 40 years old with infrequent menstruation or amenorrhea for at least 4 months and FSH levels greater than 25 IU/L on two occasions spaced more than 4 weeks apart. (3) Voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Primary amenorrhea; (2) Various diseases affecting ovarian function such as chromosomal abnormalities thyroid or adrenal diseases chronic debilitating diseases malignant tumors nutritional metabolic diseases and severe malnutrition; (3) Individuals with liver or kidney dysfunction; (4) Uncontrolled and/or undiagnosed medical conditions that may interfere with or affect the study treatment such as severe liver heart kidney or brain diseases; (5) Individuals with severe mental illnesses who are unable to cooperate; (6) Individuals who have participated in other clinical trials within the last 3 months; (7) Individuals with allergic constitutions or allergies to the study medication; (8) Individuals who have not signed the informed consent form.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Six reproductive hormone routines;Total score of menstrual symptoms;

Secondary

MeasureTime frame
improved Kupperman Score scale;

Countries

China

Contacts

Public ContactYIzhou Zhang

Zhejiang Chinese Medical University

zhangyizhou2005@126.com13600539822

Outcome results

None listed

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