Status:
UNKNOWN
QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
Lead Sponsor:
Yun Chen
Conditions:
Menopause
Eligibility:
FEMALE
45-55 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to explore the differences of intestinal flora and saliva flora between menopausal women, and the changes after medication, to find the association between the two a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06143696
Start Date
August 1 2023
End Date
June 30 2025
Last Update
November 22 2023
Active Locations (1)
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1
Yuxin Zhou
Nanjing, Jiangsu, China