Clinical trial NCT06143696: QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Keywords: menopause
16S rRNA
saliva flora
intestinal flora
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 16s rRNA high-throughput sequencing of the gut flora
timeFrame: Baseline (Before treatment) and 12th weeks of treatment
measure: 16s rRNA high-throughput sequencing of the saliva flora
timeFrame: Baseline (Before treatment) and 12th weeks of treatment
Secondary outcomes:
measure: Hot flashes and sweating on a five-point scale.
timeFrame: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
measure: Modified Kupperman rating scale
timeFrame: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yuxin Zhou
state: Jiang Su
Study officials:
References: