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

Launched by TONGJI HOSPITAL · Aug 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a Chinese herbal compound called TJAOA102 to see if it can help relieve symptoms of menopausal syndrome in women. Menopausal syndrome can cause various symptoms like hot flashes, mood changes, and sleep problems. The researchers have already tested this herbal compound on animals and want to confirm its safety and effectiveness with women aged 18 to 55 who are experiencing menopause issues, such as diminished ovarian reserve (DOR) or primary ovarian insufficiency (POI).

To participate in the trial, women should be within the specified age range and have a diagnosis related to menopause. They will need to sign a consent form to show they understand the study. However, some women cannot join, including those who are pregnant, have certain medical conditions, or are taking specific medications. While the study is not yet recruiting participants, those who take part can expect to help advance the understanding of traditional Chinese medicine in treating menopausal symptoms, contributing to future treatments for many women.

Gender

FEMALE

Eligibility criteria

• 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.