Granules and decoction pieces of Huyang yangkun formula delaying ovarian decline in patients with premature ovarian insufficiency: a double-blind randomized controlled study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083926

Enrollment

Unknown

Registered

2024-05-07

Start date

2024-05-08

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Premature ovarian insufficiency(POI)

Interventions

TCM Granules Treatment Group:Granules of Huyang Yangkun Formula

TCM decoction treatment group:Decoction pieces of Huyang Yangkun Formula

Control group:placebo granules

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? POI patients with reproductive needs in the gynecology department of Guangdong Provincial Hospital of Traditional Chinese Medicine who meet the diagnostic criteria of TCM and Western medicine ? Aged between 18-40 years. ? The duration of natural menstrual cessation is less than 6 months. ? No follicles with a diameter greater than 10mm were found in both ovaries; E2 = 100pmol/L ? Chromosomes are normal. ? Agree to participant the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: ? Menstrual disorders caused by congenital hypogonadism and acquired organic diseases. ?Menstrual disorders caused by endocrine diseases such as polycystic ovary syndrome. hyperprolactinemia, dysfunctional uterine bleeding, hypogonadotropin, hyperthyroidism and other endocrine diseases (disorders). ? Allergic to treatment drugs. ? Body mass index=30 kg/m2. ? Smoking=10 cigarettes/day. ? Abnormal vaginal bleeding within the past 12 months, endometrial biopsy suggests clinically relevant abnormalities, or undiagnosed irregular vaginal bleeding; Suspected cervical cancer or cervical precancerous lesions; suspected breast cancer; known or suspected history of hormone-dependent tumors or malignant tumors. ? Patients with severe mental illness; clinically considered obvious suicidal tendency. ? Uncontrolled and/or diagnosed medical conditions that may interfere with or affect study treatment, for example, severe liver, kidney, heart, or brain disease; cholecystitis or gallstones; uncontrolled or untreated hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); or abnormal thyrotropin may cause symptoms similar to menopause. ? Those who have participated in other clinical trials in the past 3 months.

Design outcomes

Primary

Measure	Time frame
Follicle growth vitality;	—

Secondary

Measure	Time frame
Antral follicle count;Ovarian volume;Follicle stimulating hormone;Estradiol;AMH;	—

Countries

China

Contacts

Public ContactHongyan Yang

Guangdong Provincial Hospital of Chinese Medicine

hongyanyang@gzucm.edu.cn+86 136 6246 5058

Outcome results

None listed

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