QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
NCT ID: NCT06143696
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-01
2025-06-30
Brief Summary
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* What are the differences in intestinal flora and saliva flora in menopausal women with hot flashes and sweating.
* Whether these differences change after using traditional Chinese medicine and the association between intestinal, salivary flora and menopausal syndrome.
60 patients will be screened according to the clinical experimental criteria. They will be randomly divided into trial group (30 cases) and control group (30 cases). The test group takes traditional Chinese medicine Qingxin Zishen decoction, and the control group takes oral Femoston, comparing the two groups with analysis of symptom improvement, intestinal flora and salivary flora with 16S rRNA sequencing technology.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the experimental group
Qingxin Zishen decoction, oral administration, 1 dose a day, 2 times a day. For 28 days of medication, every 28 days. Observation time for 3 courses.
Qingxin Zishen decoction
Oral administration, 1 dose daily, twice a day
the control group
Femoston, oral, 1 each time, once a day. For 28 days of medication, every 28 days. Observation time for 3 courses.
Femoston
Oral administration, 1 pill each time, once a day
Interventions
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Qingxin Zishen decoction
Oral administration, 1 dose daily, twice a day
Femoston
Oral administration, 1 pill each time, once a day
Eligibility Criteria
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Inclusion 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
* 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.
45 Years
55 Years
FEMALE
No
Sponsors
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Yun Chen
OTHER
Responsible Party
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Yun Chen
Deputy Chief Physician
Locations
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Yuxin Zhou
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QXZS-Flora
Identifier Type: -
Identifier Source: org_study_id