Menopausal Syndrome Clinical Trial
Official title:
The Efficacy and Safety of Chinese Herbal Compound TJAOA102 in the Treatment of Menopausal Syndrome: A Multicenter, Prospective and Before-after Study.
Verified date | August 2022 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluating the change of Kupperman Index Score(KMI) | Assessing the KMI before and after the treatment of TJAOA102 | 6 months | |
Secondary | recovery rate of ovarian function | 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. | 6 months |
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