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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06271928
Other study ID # TJ-IRB20220634-yijingkeli
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 1, 2021
Est. completion date January 1, 2025

Study information

Verified date February 2024
Source Tongji Hospital
Contact jinjin zhang, professor
Phone +8683663078
Email jinjinzhang@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Yijing Keli
Once enrolled, participants will be administrated Yijing Keli

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

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
See also
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Completed NCT01572025 - Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging Phase 3
Recruiting NCT06256783 - A Clinical Study of Baozhu Keli in the Treatment of Ovarian Aging Early Phase 1