A Clinical Study of Baozhu Keli in the Treatment of Ovarian Aging

NCT ID: NCT06256783

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-01-31

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 Baozhu 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 Baozhu Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA.

Conditions

Ovarian Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Once enrolled, participants will be administrated Baozhu 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.

Group Type: EXPERIMENTAL

Baozhu Keli

Intervention Type: DRUG

Once enrolled, participants will be administrated Baozhu Keli

Interventions

Baozhu Keli

Once enrolled, participants will be administrated Baozhu Keli

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The age range of patient is 18-40 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinjin Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinjin Zhang, Professor

Role: STUDY_CHAIR

Tongji Hospital

Locations

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

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinjin Zhang, Professor

Role: CONTACT

jinjinzhang@tjh.tjmu.edu.cn

+8683663078

Yan Zhang, MD

Role: CONTACT

+8683663078

Facility Contacts

Yan Zhang, MD

Role: primary

zhangyanmedicine@163.com

+8683663078

Other Identifiers

TJ-IRB20220634-baozhukeli

Identifier Type: -

Identifier Source: org_study_id