Ovarian Aging
Conditions
Brief summary
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.
Interventions
DRUGYijing Keli
Once enrolled, participants will be administrated Yijing Keli
Sponsors
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the recovery rate of ovarian function | 6 months | 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. |
Countries
China
Contacts
Primary Contactjinjin zhang, professor
Backup Contactyan zhang, MD
Outcome results
None listed