A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271928
• Other study ID #: TJ-IRB20220634-yijingkeli
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Ovarian Aging

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