A randomized, double-blind, placebo-controlled study of Tonifying the kidney, regulating the spleen and soothing the liver in the treatment of early-onset ovarian insufficiency

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006811

Enrollment

Unknown

Registered

2022-11-22

Start date

2022-11-25

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

Premature ovarian insufficiency

Interventions

Experimental Group:Granules of Tonifying the kidney, regulating the spleen and soothing the liver: 11g/bag,1bag/time,2time/day,boiled water.

Control group:Mimetic granules of Tonifying the kidney, regulating the spleen and soothing the liver: 11g/bag,1bag/time,2time/day,boiled water.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old; (2) Meets POI diagnostic criteria and 25 IU<FSH=40 IU/L (4 weeks apart=); (3) Those who have not taken traditional Chinese and Western medicine treatment drugs related to this disease within three months; (4) Those who voluntarily participate in this clinical study and sign an informed consent form; (5) Those who have not participated in other clinical trials within three months.

Exclusion criteria

Exclusion criteria: (1) Congenital abnormal development of reproductive organs, primary or secondary amenorrhea caused by acquired genital diseases and injuries, amenorrhea or menstrual sporation caused by various diseases such as hypothalamus and pituitary lesions; (2) Combined with other endocrine or metabolic immune system diseases affecting ovarian function, such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, thyroid dysfunction, functional hypothalamic amenorrhea, ovarian resistance syndrome, etc.; (3) Early-onset ovarian insufficiency caused by chromosomal abnormalities and gene mutations, iatrogenic factors (surgery, radiotherapy, chemotherapy); (4) Those who are allergic to a variety of drugs or are known to be allergic or contraindicated to the composition of this drug; (5) Have received hormonal drugs with therapeutic effects on the disease in the past 1 month and non-drug treatment such as acupuncture (6) Patients with serious diseases of the heart, liver, kidneys or/or hematopoietic system and mental disorders.

Design outcomes

Primary

Measure	Time frame
FSH;	—

Secondary

Measure	Time frame
AFC;TCM certificate score;AMH;Improved Kupperman score;Quantitative scoring of menstrual conditions;	—

Countries

China

Contacts

Public ContactTengXiuxiang

tengxx@126.com13717987052

Outcome results

None listed

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