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Clinical study of Heyan Kuntai capsule in the treatment of diminished ovarian function

Clinical study of Heyan Kuntai capsule in the treatment of diminished ovarian function: a multicenter, randomized, double-blind, parallel-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009199
Enrollment
Unknown
Registered
2016-09-13
Start date
2016-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Diminished ovarian function

Interventions

The experimental group:Heyan Kuntai capsule+conventional therapy
The control group:Placebo+conventional therapy

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 42 Years

Inclusion criteria

Inclusion criteria: 1. Aged 25-42 years old; 2. 0.5 ng/ml < anti-mullerian hormone (AMH)<1.1 ng/ml; 3. 10 mIU/ml= follicle stimulating hormone (FSH)<30 mIU/ml; 4. Voluntary partcipants, and agreed to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with premature ovarian failure (bFSH=40 mIU/ ml); 2. endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine muscle tumors> 4 cm; 3. for patients with fertility requirements: genetic factors, tubal factors, congenital birth defects or abnormal development, or male's factors caused infertility; 4. patients underwent hysterectomy; 5. allergic; 6. serious primary cardiovascular, liver, kidney, hematopoietic system, and mental diseases; 7. patients who are participating in other clinical trials, or participated in other clinical trials within the past month; 8. suspected or indeed alcohol, drug abuse history; or patients who have other complicated diseases or conditions, such as frequent changes in the working and living environment to cause low compliance; 9. patients taking cold medicine during the treatment; 10. the investigators identified patients unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Antral follicle count (AFC);Anti-mullerian hormone (AMH);

Secondary

MeasureTime frame
Follicle stimulating hormone (FSH);Luteinizing hormone (LH);Estradiol (E2);Pregnancy rate;

Countries

China

Contacts

Public ContactYu Qi

Peking Union Medical College Hospital

13701227034@163.com+86 13701227034

Outcome results

None listed

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