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Randomized, double-blind, placebo-controlled, multicenter clinical trial of efficacy and safety of Wuji Baifeng Tablet in the treatment of ovarian reserve deficiency (deficiency of qi and blood, d

Randomized, double-blind, placebo-controlled, multicenter clinical trial of efficacy and safety of Wuji Baifeng Tablet in the treatment of ovarian reserve deficiency (deficiency of qi and blood, d

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005466
Enrollment
Unknown
Registered
2021-12-29
Start date
2021-12-29
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

DOR

Interventions

Sponsors

Peking University Third Hospital
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 reduced ovarian reserve function; (2) Meet the TCM syndrome differentiation standards of deficiency of qi and blood and deficiency of liver and kidney; (3)20 = age < 40; (4) The patient shall give informed consent and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with definite diagnosis of POI; Patients with ovarian resistance syndrome, abnormal reproductive tract development, polycystic ovary syndrome, hyperprolactinemia, ovarian endometriosis, central nervous system tumors, functional hypothalamic amenorrhea, thyroid dysfunction, adrenal cortex dysfunction and other related symptoms; (2) women who are pregnant or breastfeeding or have a history of abortion in the last 1 month; (3) patients with serious primary diseases of heart, brain, liver, kidney, hematopoietic and immune systems, blood-borne infectious diseases and mental disorders; (4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 2 times of the upper limit of normal value, and serum creatinine (Cr) was more than the upper limit of normal value; (5) Those who had received hormone supplement therapy (HRT) and/or had taken Traditional Chinese medicines such as supplementing qi and blood, regulating liver and kidney in 1 month before enrollment, and the efficacy of drugs was difficult to judge; (6) with mental disorders, including anxiety disorder (HAMA=14 points), depression (HAMD=17 points), etc.; (7) allergic to the drug ingredients in the known experimental drug; (8) Participate in other clinical studies within 1 month prior to screening.

Design outcomes

Primary

MeasureTime frame
FSH;

Secondary

MeasureTime frame
Disappearance rate of single symptom;HAMD;AFC;PBAC;Sex hormone change value;AMH;HAMA;TCM syndrome is efficient;

Countries

china

Contacts

Public Contactlirong
lirong_0101@163.com13701085402

Outcome results

None listed

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