An interventional study of Qingxin Zishen decoction and Femoston in Menopause, sponsored by Yun Chen. Recruiting at 1 site in China. Open to female participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Yun Chen · Not applicable, Interventional, and Treatment
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:
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.
Yun Chen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Informed consent, voluntary test. The process of obtaining informed consent should be in accordance with GCP regulations.
Exclusion Criteria:
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.
Drug: Qingxin Zishen decoction
Femoston, oral, 1 each time, once a day. For 28 days of medication, every 28 days. Observation time for 3 courses.
Drug: Femoston
Oral administration, 1 dose daily, twice a day
Oral administration, 1 pill each time, once a day
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.
Time frame: 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.
Time frame: Baseline (Before treatment) and 12th weeks of treatment
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.
Time frame: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
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
Time frame: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
Plan to share: No
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