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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 and menopausal syndrome. The main questions it aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the experimental group | Experimental | 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. |
|
| the control group | Active Comparator | Femoston, oral, 1 each time, once a day. For 28 days of medication, every 28 days. Observation time for 3 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qingxin Zishen decoction | Drug | Oral administration, 1 dose daily, twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 16s rRNA high-throughput sequencing of the gut flora | 16s rRNA is a highly conserved gene segment in bacteria and archaea, together with some variability. Sequencing the 16S rRNA gene allowed us to identify different genera and species present in the microbial community and to assess their relative abundance. | Baseline (Before treatment) and 12th weeks of treatment |
| 16s rRNA high-throughput sequencing of the saliva flora | 16s rRNA is a highly conserved gene segment in bacteria and archaea, together with some variability. Sequencing the 16S rRNA gene allowed us to identify different genera and species present in the microbial community and to assess their relative abundance. | Baseline (Before treatment) and 12th weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hot flashes and sweating on a five-point scale. | The symptoms of hot flashes and sweating were recorded as none, mild, moderate, severe, and very severe, and were recorded as 0, 1, 2, 3, and 4 points. The individual scores of the two groups before and after treatment at the end of the 4th, 8th and 12th weeks were compared. | Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment |
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Inclusion Criteria:
Informed consent, voluntary test. The process of obtaining informed consent should be in accordance with GCP regulations.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Chen | Contact | +8615151835610 | fsyy00684@njucm.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuxin Zhou | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| C472241 | femoston |
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| Femoston |
| Drug |
Oral administration, 1 pill each time, once a day |
|
| Modified Kupperman rating scale | The Kupperman Index (KMI) score was used to include 13 menopausal related symptoms such as vasomotor symptoms, paresthesias, insomnia, etc., and each symptom was divided into 0-3 points according to severity, and multiplied by different coefficients to obtain the menopausal symptom index, when the index > 35 indicates severe symptoms, 21-35 indicates moderate symptoms, and 15-20 indicates mild symptoms. The individual scores and total scores of the two groups before and after treatment at the 4th, 8th and 12th weekends were compared | Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment |