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Huyang yangkun formula delaying ovarian decline in patients with premature ovarian insufficiency: a double-blind randomized controlled study

Huyang yangkun formula delaying ovarian decline in patients with premature ovarian insufficiency: a double-blind randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005144
Enrollment
Unknown
Registered
2021-08-06
Start date
2021-11-01
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(POI)

Interventions

Experimental group:Herbal concentrate-granules Huyang Yangkun formula
Control group:Placebo

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of TCM and Western medicine for premature ovarian insufficiency spleen and kidney yang deficiency. 2. Aged between 18-39 years. 3. Clinically abnormal period POI: The obvious incentives are oligomenorrhea (menstrual cycle is more than 35 days), and it lasts for more than 2 consecutive cycles; the natural menstrual period is less than 6 months, and the bFSH of 4 weeks between the two times is greater than 25 U/L. 4. Sex hormone drugs within the past 3 months. 5. Sign the informed consent form, voluntarily participate in the project survey, and answer the survey questions truthfully.

Exclusion criteria

Exclusion criteria: 1. Menstrual disorders caused by congenital hypogonadism and acquired organic diseases; 2. Menstrual disorders caused by endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, hypogonadotropin, hyperthyroidism and other endocrine diseases (disorders); 3. Infertile patients treated with assisted reproductive technology; 4. Abnormal vaginal bleeding within the past 12 months, endometrial biopsy suggests clinically relevant abnormalities, or undiagnosed irregular vaginal bleeding; 5. Suspected cervical cancer or cervical precancerous lesions; suspected breast cancer; known or suspected history of hormone-dependent tumors or malignant tumors; 6. Patients with severe mental illness; clinically considered obvious suicidal tendencies; 7. Uncontrolled and/or diagnosed medical conditions that may interfere with or affect study treatment, for example, severe liver, kidney, heart, or brain disease; 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; 8. Pregnant or lactating patients; 9. Those who have participated in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Greene scale;Estradiol;Follicle stimulating hormone;Menstrual cycle;Luteinizing hormone;Follicle growth and development;Female sexual function index;

Countries

China

Contacts

Public ContactYang Hongyan

Guangdong Provincial Hospital of Chinese Medicine

hongyanyang@gzucm.edu.cn+86 13662465058

Outcome results

None listed

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