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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05522634
Other study ID # TJ-IRB20220634-POI
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date November 1, 2022
Est. completion date November 1, 2024

Study information

Verified date October 2022
Source Tongji Hospital
Contact Shixuan Wang, Professor
Phone +8613995553319
Email shixuanwang@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, 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 TJAOA101 in therapy of POI. We aim to provide a solid evidence for TCM in therapy of POI.


Description:

Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated in multi-center and prospective clinical trials. We are conducting a prospective and before-after clinic trial with 100 eligible women aged 18-40 diagnosed POI will be participated. All participants will be administrated TJAOA101 drug twice every day for overall 3 months. The primary outcomes will be the basal level of serum FSH. The second outcome is the recovery rate of menstruation. All the outcomes will be assessed at baseline and 1, 2, 3 months following the 3 months' treatment. Adverse events(AEs) of patients will be assessed during the follow-up. The study was approved by the Medical Ethics Committee of the Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20220634) according to the submitted study protocol (V.2.1, 10 May 2022) and informed consent (V.2.1, 10 May 2022). The results will be presented at domestic and international conferences and published in peer reviewed journals.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 1, 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. The age range of patient is 18-40 years old. 2. The diagnostic criteria for POI is as follows: Age <40; and menopause or sporadic menstruation for more than 4 months; and bFSH>25 mIU/ml (the interval between two reexaminations should be more than one month, both reached this level) 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. Patients had been menopause for more than 1 year. 4. Abnormal uterine bleeding, except ovulation disorders. 5. Women is taking hormone drugs and has stopped taking them within 3 months; 6. Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm. 7. The nature of pelvic mass is unknown. 8. Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation. 9. Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients. 10. Patients are participating in other clinical trials or have participated in other clinical trials within the last month. 11. Unsuitable for the study evaluated by the investigator.

Study Design


Intervention

Drug:
TJAOA101
Once enrolled, participants will be administrated TJAOA101

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary recovery rate of ovarian function As the definition of POI is based on menstruation and bFSH, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum bFSH decreased more than 50%, or recover to normal level; or two consecutive periods return to normal. 6 months
Secondary serum AMH serum AMH increased more than 50%, or recover to normal level. 6 months
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