Exploring the effects of traditional Chinese medicine on menopausal symptoms
Study on the (Heart) Brain-gut Axis Mechanism of Qingxin Zishen Decoction in Treating Hot Flashes in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
This study is testing whether a traditional Chinese medicine can help menopausal women with hot flashes and sweating feel better by looking at changes in their gut and saliva bacteria compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 55 Years |
| Sex | Female |
| Sponsor | Jiangsu Province Hospital of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Nanjing, Jiang Su) |
| Trial ID | NCT06143696 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the differences in intestinal and saliva flora among menopausal women, particularly focusing on those experiencing hot flashes and sweating. It aims to determine how these flora change after treatment with traditional Chinese medicine, specifically Qingxin Zishen decoction, compared to a control group receiving Femoston. The study will involve 60 participants who will be randomly assigned to either the treatment or control group, with assessments made on symptom improvement and flora analysis using 16S rRNA sequencing technology.
Who should consider this trial
Good fit: Ideal candidates are women aged 45-55 who meet the diagnostic criteria for menopausal syndrome and experience significant symptoms such as hot flashes.
Not a fit: Patients who have used other treatments for menopausal syndrome or have serious underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into alternative treatments for menopausal symptoms, potentially improving quality of life for women experiencing these issues.
How similar studies have performed: While there is ongoing research into the effects of flora on health, this specific approach using traditional Chinese medicine in menopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those who meet the diagnostic criteria for menopausal syndrome and the TCM heart and kidney syndrome differentiation criteria. * Women between the ages of 45\~55. * The score of the modified Kupperman Menopausal Symptom Rating Scale ≥ 15 points. * Hot flashes and sweating≥ 3 times/day. * Menopause ≥ 6 months. * FSH \> 10U/L during menopausal transition, 40U/L \> after menopause, and estradiol (E2) \< (10\~20) pg/mL. Informed consent, voluntary test. The process of obtaining informed consent should be in accordance with GCP regulations. Exclusion Criteria: * Other Chinese and Western drugs for the treatment of menopausal syndrome have been used after the onset of the disease. * Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival. * Contraindications to hormone therapy: known or suspected pregnancy; In perimenopausal women, menstrual disorders should be ruled out to exclude pregnancy-related problems such as intrauterine pregnancy, ectopic pregnancy, and trophoblastic disease. Unexplained vaginal bleeding: Causes of vaginal bleeding include neoplastic, inflammatory, iatrogenic, traumatic, and ovarian dysfunction, which should be carefully identified before perimenopausal menstrual disorders are treated with sex hormones. Known or suspected breast cancer. Known or suspected sex hormone-dependent malignancy. Active venous or arterial thromboembolic disease within the last 6 months. Severe hepatic and renal insufficiency. * Those who are unable to give full informed consent due to intellectual or behavioral disabilities. * Suspected or confirmed history of alcohol and drug abuse. * Allergies, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of this medicine. * Patients who are participating in clinical trials of other drugs.
Where this trial is running
Nanjing, Jiang Su
- Yuxin Zhou — Nanjing, Jiang Su, China (Recruiting)
Study contacts
- Study coordinator: Yun Chen
- Email: fsyy00684@njucm.edu.cn
- Phone: +8615151835610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.