QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143696
• Other study ID #: QXZS-Flora
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Jiangsu Province Hospital of Traditional Chinese Medicine
• Contact: Yun Chen
• Phone: +8615151835610
• Email: fsyy00684[@]njucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Qingxin Zishen decoction
Oral administration, 1 dose daily, twice a day
• Femoston
Oral administration, 1 pill each time, once a day

Locations

Country	Name	City	State
China	Yuxin Zhou	Nanjing	Jiang Su

Sponsors (1)

Lead Sponsor	Collaborator
Yun Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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