Study on the (Heart) Brain-gut Axis Mechanism of Qingxin Zishen Decoction in Treating Hot Flashes in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 55
Healthy Volunteers: f
View:

• Those who meet the diagnostic criteria for menopausal syndrome and the TCM heart and kidney syndrome differentiation criteria.

• Women between the ages of 45\

• 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\

⁃ pg/mL.

‣ Informed consent, voluntary test. The process of obtaining informed consent should be in accordance with GCP regulations.

Locations
Other Locations
China
Yuxin Zhou
RECRUITING
Nanjing
Contact Information
Primary
Yun Chen
fsyy00684@njucm.edu.cn
+8615151835610
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Active_comparator: the control group
Femoston, oral, 1 each time, once a day. For 28 days of medication, every 28 days. Observation time for 3 courses.
Related Therapeutic Areas
Sponsors
Leads: Yun Chen

This content was sourced from clinicaltrials.gov