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

Early Phase 1

Recruiting

• Conditions: Ovarian Aging
• Interventions: Drug: Baozhu Keli

• Registration Number: NCT06256783
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Baozhu Keli	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.

Primary Outcome Measures

Name	Time	Method
the recovery rate of ovarian function	6 months	evaluations of ovarian reserve 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.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China