NCT05522634

A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency

The Efficacy and Safety of Chinese Herbal Compound TJAOA101 in the Treatment of POI: A Multicenter, Prospective and Before-after Study.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
DRUG	TJAOA101	Once enrolled, participants will be administrated TJAOA101

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2022-08-31
• Last updated: 2022-10-20

Locations

1 site across 1 country: China