Evaluating the effects of Qingxin Zishen Decoction on ovarian reserve function
Real-world Evaluation of the Clinical Efficacy of Qingxin Zishen Decoction in Patients With Reduced Ovarian Reserve
This study is testing if a traditional herbal remedy called Qingxin Zishen Decoction can help improve ovarian function in women aged 25 to 45 who have reduced ovarian reserve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 178 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Jiangsu Province Hospital of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06332742 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical efficacy of Qingxin Zishen Decoction in improving ovarian reserve function in women aged 25 to 45 with decreased ovarian reserve. The study will involve a prospective cohort of patients who meet specific eligibility criteria related to hormonal levels and ovarian function. Participants will be monitored for changes in ovarian reserve markers over the course of the study, providing real-world evidence of the decoction's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25 to 45 with specific hormonal indicators of decreased ovarian reserve.
Not a fit: Patients with ovarian reserve issues due to surgical interventions, chemotherapy, or those with significant liver or kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new therapeutic option for women experiencing decreased ovarian reserve, potentially improving their fertility outcomes.
How similar studies have performed: While there is limited information on the success of similar studies, the use of traditional Chinese medicine in fertility treatments has shown promise, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
1.AMH AMH \<1.1ng/ml 2.AFC: AFC \<5\~7 ovaries on both sides 3.Basic FSH: Basal FSH for two consecutive menstrual cycles ≥10 IU/L 4.Aged between 25 and 45 years old, female. 1. Those with reduced ovarian function caused by ovarian or uterine surgery, radiotherapy and chemotherapy; 2. Liver function (AST or ALT) and renal function (BUN or Ccr) are greater than 2 times the normal value; 3. Patients with a history of mental illness or legal disability 4. Those who have used endocrine-affecting drugs within 3 months before the study, estrogen, progesterone or related compound preparations, oral contraceptive pills, Chinese medicines or Chinese patent medicines related to the treatment of premature ovarian failure. Our hospital's preparations include Wu Turtle Rejuvenation Oral Liquid and Kuntai Capsules. 5. Patients with unexplained irregular vaginal bleeding 6. Patients who are participating in clinical trials of other drugs 7. For women who want to have children, those whose spouse's semen test fails to meet the standard will be excluded.
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Chen Yun
- Email: 66teoyq@gmail.com
- Phone: 8613675167221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.