QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

NCT06143696 | Unknown

• 1 other identifier: QXZS-Flora
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Menopause

Keywords

menopause; 16S rRNA; saliva flora; intestinal flora

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Hot flashes and sweating on a five-point scale.

  Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment

• Modified Kupperman rating scale

  Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment

Study Arms (2)

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.

Drug: Qingxin Zishen decoction

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.

Drug: Femoston

Interventions

Qingxin Zishen decoction DRUG

Oral administration, 1 dose daily, twice a day

the experimental group

Femoston DRUG

Oral administration, 1 pill each time, once a day

the control group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Chen: lead

Study Sites (1)

Yuxin Zhou

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

femoston

Central Study Contacts

Yun Chen

CONTACT

+8615151835610; fsyy00684@njucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)