A Muticenter Clinical Study of Chinese Herbal Compound TJAOA102 in

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05522621
Study type	Interventional
Source	Tongji Hospital
Contact
Status	Not yet recruiting
Phase	Early Phase 1
Start date	October 1, 2022
Completion date	October 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms