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

Tongji Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Ovarian Aging

Treatments: Drug: Baozhu Keli

Study type: Interventional

Funder types: Other

Identifiers

NCT06256783

TJ-IRB20220634-baozhukeli

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment group

Experimental group

Description:

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.

Treatment:

Drug: Baozhu Keli