Using Baozhu Keli to treat ovarian aging
The Efficacy and Safety of Chinese Herbal Compound Baozhu Keli in the Treatment of Ovarian Aging: A Multicenter and Prospective Study.
This study tests if a new Chinese herbal remedy called Baozhu Keli can help women aged 18 to 40 with ovarian aging feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT06256783 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the safety and efficacy of a new Chinese herbal combination called Baozhu Keli for treating ovarian aging in women aged 18 to 40. The study is designed as a multicenter, population-based trial to gather evidence supporting the use of traditional Chinese medicine in addressing ovarian aging. Participants will be monitored for their response to the treatment, and the findings aim to validate the therapeutic potential of this herbal remedy.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 who have been diagnosed with ovarian aging.
Not a fit: Patients who are pregnant, lactating, or have certain endocrine disorders or serious primary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the physical and mental health of women experiencing ovarian aging.
How similar studies have performed: While the use of Chinese herbs in treating ovarian aging is promising, this specific approach with Baozhu Keli is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The age range of patient is 18-40 years old. 2. The diagnostic criteria for ovarian aging. 3. Sign the informed consent form. Exclusion Criteria: 1. Patient is known to be allergic or unsuitable for the Chinese herbal compound. 2. Women who are pregnant and lactating. 3. Abnormal uterine bleeding, except ovulation disorders. 4. Women is taking hormone drugs and has stopped taking them within 3 months; 5. Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm. 6. The nature of pelvic mass is unknown. 7. Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation. 8. Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb\<90g/L) and malignant tumor, and psychiatric patients. 9. Patients are participating in other clinical trials or have participated in other clinical trials within the last month. 10. Unsuitable for the study evaluated by the investigator.
Where this trial is running
Wuhan
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)
Study contacts
- Study coordinator: Jinjin Zhang, Professor
- Email: jinjinzhang@tjh.tjmu.edu.cn
- Phone: +8683663078
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.