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

Early Phase 1

Not yet recruiting

• Conditions: Menopausal Syndrome
• Interventions: Drug: TJAOA102

• Registration Number: NCT05522621
• Lead Sponsor: Tongji Hospital

Brief 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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Study First Posted: 2022-08-31
• Last Update Posted: 2022-08-31
• Study Start: 2022-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. The age range of patient is 18-55 years old.
2. The diagnosis of women is DOR, POI, early menopause or menopausal syndrome, and wish to improve ovarian function or menopausal syndrome.
3. Sign the informed consent form.

Exclusion Criteria

(1) The patient is known to be allergic or unsuitable for the Chinese herbal compound. (2) Women who are pregnant and lactating.

(3) Patients of POI or DOR had been menopause for more than 1 year. (4) Abnormal uterine bleeding, except ovulation disorders. (5) Women who is taking hormone drugs and has stopped taking them within 3 months; (6) The diagnosis of women is 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) The diagnosis of women is 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 who are participating in other clinical trials or have participated in other clinical trials within the last month.

(11) Patients who are unsuitable for the study evaluated by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TJAOA102	TJAOA102	Once enrolled, participants will be administrated TJAOA102 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.

Primary Outcome Measures

Name	Time	Method
Evaluating the change of Kupperman Index Score（KMI）	6 months	Assessing the KMI before and after the treatment of TJAOA102

Secondary Outcome Measures

Name	Time	Method
recovery rate of ovarian function	6 months	the recovery of ovarian function is defined as serum AMH increased more than 50%, or serum bFSH decreased more than 50%, or antral follicle count(AFC) increased more than 50% compared with that before treatment，or recover to normal level.