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A randomized, double-blind, placebo-controlled, multicenter clinical trial of efficacy and safety of Wuji Baifeng Tablets in the treatment of premature ovarian insufficiency (Qi and blood deficiency, liver and kidney deficiency syndrome)

A randomized, double-blind, placebo-controlled, multicenter clinical trial of efficacy and safety of Wuji Baifeng Tablets in the treatment of premature ovarian insufficiency (Qi and blood deficiency, liver and kidney deficiency syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054952
Enrollment
Unknown
Registered
2021-12-29
Start date
2021-12-29
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

premature ovarian insufficiency

Interventions

Sponsors

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for early-onset ovarian insufficiency; 2. Comply with the TCM syndrome differentiation standard of TCM deficiency of qi and blood and deficiency of liver and kidney; 3. Aged >=20 years and < 40; 4. The patient himself gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Ovarian resistance syndrome, reproductive tract dysplasia, polycystic ovary syndrome, hyperprolactinemia, ovarian endometriosis, central nervous system tumors, functional hypothalamic amenorrhea, abnormal thyroid function, abnormal adrenal cortex function and other related symptoms; 2. Pregnant or lactating patients or have a history of miscarriage in the past 1 month; 3. Patients with serious primary diseases of the heart, brain, liver, kidney, hematopoietic and immune systems, blood infectious diseases and mental illness; 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are more than 2 times the upper limit of normal, and serum creatinine (Cr) is greater than the upper limit of normal; 5. Those who have undergone hormone replacement therapy (HRT) and (or) have taken traditional Chinese medicines of nourishing qi and blood, regulating liver and kidney 1 month before enrollment, making it difficult to judge the efficacy of the drugs; 6. Combined with mental disorders, including anxiety disorder (HAMA>=14 points), depression (HAMD>=17 points), etc.; 7. Those who are allergic to the drug components in the known experimental drugs; 8. Participate in other clinical studies within 1 month before screening.

Design outcomes

Primary

MeasureTime frame
Follicle stimulating hormone;

Secondary

MeasureTime frame
Sex hormone change value;Changes in anti-mullerian hormone;Antral follicle change value;Efficiency of TCM syndrome;Disappearance rate of single symptom;Modified Kupperman score;Changes in Hamilton anxiety scale scores;Hamilton depression scale change values;

Countries

China

Contacts

Public ContactRuan Xiangyan

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

ruxiangyan_0101@163.com+86 13011215678

Outcome results

None listed

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