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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.


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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
  Status Clinical Trial Phase
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