QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

NCT06143696 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-22

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Qingxin Zishen decoction

Oral administration, 1 dose daily, twice a day

DRUG

Femoston

Oral administration, 1 pill each time, once a day

Sponsors & Collaborators

  • Yun Chen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-08-31
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06143696 on ClinicalTrials.gov