QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

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

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.

Study Overview

• Status: Recruiting
• Conditions: Menopause
• Intervention / Treatment: Drug: Qingxin Zishen decoction; Drug: Femoston

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Chen; Phone Number: +8615151835610; Email: fsyy00684@njucm.edu.cn

Study Locations

• China
  • Jiang Su
    • Nanjing, Jiang Su, China
      • Recruiting
      • Yuxin Zhou
      • Contact: Yuxin Zhou; Phone Number: +8615151835610; Email: zyxemilia@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

• Other Chinese and Western drugs for the treatment of menopausal syndrome have been used after the onset of the disease.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Qingxin Zishen decoction; Oral administration, 1 dose daily, twice a day
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.	Drug: Femoston; Oral administration, 1 pill each time, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Yun Chen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: menopause; 16S rRNA; intestinal flora; saliva flora
• Other Study ID Numbers: QXZS-Flora

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No