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

NCT06271928 | Recruiting Early Phase 1 DMC

• 1 other identifier: TJ-IRB20220634-yijingkeli
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Aging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Interventions

Yijing Keli DRUG

Once enrolled, participants will be administrated Yijing Keli

Treatment group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The age range of patient is 18-55 years old.
• The diagnostic criteria for ovarian aging.
• Sign the informed consent form.

You may not qualify if:

• Patient is known to be allergic or unsuitable for the Chinese herbal compound.
• Women who are pregnant and lactating.
• Abnormal uterine bleeding, except ovulation disorders.
• Women is taking hormone drugs and has stopped taking them within 3 months;
• Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
• The nature of pelvic mass is unknown.
• Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
• Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb\<90g/L) and malignant tumor, and psychiatric patients.
• Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
• Unsuitable for the study evaluated by the investigator.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Study Officials

• jinjin zhang, professor

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

jinjin zhang, professor

CONTACT

+8683663078; jinjinzhang@tjh.tjmu.edu.cn

yan zhang, MD

CONTACT

+8683663078

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: October 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)