Ovarian Aging Clinical Trial
Official title:
The Efficacy and Safety of Chinese Herbal Compound Yijing Keli in the Treatment of Ovarian Aging: A Multicenter and Prospective Study.
Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. The age range of patient is 18-55 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the recovery rate of ovarian function | evaluations of ovarian funtion are mainly based on the levels of AMH, basal serum FSH, and AFC. If the serum FSH level is lower than 10 mIU/mL, the serum AMH level is greater than 1.1 ng/mL, or AFC is more than 6 after treatment, it is considered effective. In addition, an improvement of more than 50% in these indicators after treatment can also be considered effective. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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