NCT05522621

A Muticenter Clinical Study of Chinese Herbal Compound TJAOA102 in Alleviating Menopausal Syndrome

The Efficacy and Safety of Chinese Herbal Compound TJAOA102 in the Treatment of Menopausal Syndrome: 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 – 55 Years
• Healthy volunteers: Not accepted

Summary

Currently, TCM recipes are widely used in treating menopausal syndrome(MS) with obvious efficiency and slight side effects. We have developed the Chinese herbal compound TJAOA102 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA102 in therapy of MS, which will provide a solid evidence for TCM in therapy of MS.

Detailed description

Early menopause which is caused by DOR and POI may accelerate the aging of women, and lead to osteoporosis, cardiovascular and cerebrovascular diseases, frequent urination, dysuria, and decreased sleep quality. Postmenopausal women may suffer from osteoporosis and atherosclerosis, coronary heart disease and high blood pressure due to elevated cholesterol, triglycerides and low-density lipoproteins. Hence, the intervention for MS is indispensable. Currently, hormonotherapy(HT) is the first-line drug therapy recommended by clinical treatment guidelines. It can add exogenous sex hormones by replenishing the lack of hormones to relieve the symptoms caused by ovarian function decline, and then improve the health and life quality.However, HT also increased the risk of breast cancer, phlebothrombosis and so on. Hence, besides HT, TCM is an effective and alternative option. To address this question, firstly we screened the database from the perspective of western medicine to identify the candidate Chinese herbs. Then multiple model organisms were used to verify their safety and effectiveness. Next, from the view of TCM, the pharmacological action, dose, synergistic effect and incompatibility were determined and finally TJAOA102, a Chinese medicine recipe for anti-ovarian aging was created. The essence of menopause is ovarian aging, so we developed anti-ovarian aging formula-TJAOA102. At present, there is no guideline for long-term TCM management in treating MS. A clinical trial is imperative to test the safety and efficacy of TCM prescription. This study is a multicenter and prospective trial aiming to determine the safety and efficacy of TJAOA102 for preventing among women who were diagnosed with MS.

Conditions

• Menopausal Syndrome

Interventions

Type	Name	Description
DRUG	TJAOA102	Once enrolled, participants will be administrated TJAOA102

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-08-31
• Last updated: 2022-08-31