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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Aging
• Intervention / Treatment: Drug: Yijing Keli

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: jinjin zhang, professor; Phone Number: +8683663078; Email: jinjinzhang@tjh.tjmu.edu.cn
• Study Contact Backup: Name: yan zhang, MD; Phone Number: +8683663078

Study Locations

• China
  • Wuhan, China
    • Recruiting
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Contact: jinjin zhang, professor; Phone Number: +8683663078; Email: jinjinzhang@tjh.tjmu.edu.cn
    • Contact: yan zhang, MD; Phone Number: +8683663078

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Once enrolled, participants will be administrated Yijing Keli and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.	Drug: Yijing Keli; Once enrolled, participants will be administrated Yijing Keli

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: jinjin zhang, professor, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TJ-IRB20220634-yijingkeli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No