Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons

Study Overview
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Brief Summary
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The goal of this clinical trial is to determine the effects of estrogen (Fenmotong) and Qingxin Zishen Decoction on the levels of kisspeptin, NKB, and dynorphin expressed in human KNDy neurons Between patients with menopausal syndrome. The aims of the study are as follows: Find a new neuroendocrine mechanism of Qingxin Zishen Decoction in the treatment of menopausal syndrome. Evaluate the changes of new neuroendocrine indicators in the clinical treatment of menopausal syndrome. Develop non-hormonal drugs with definite efficacy in the treatment of menopausal syndrome. Participants will randomly divided into the experimental group and the control group, the experimental group will be oral fenmotong, and the control group will be oral Qingxin Zi Kidney Decoction, and the efficacy, sex hormone levels and neuroendocrine index changes of the two groups will be compared.

Official Title
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Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons

Conditions
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Menopause

Intervention / Treatment
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* Drug: Femoston
* Drug: Qingxin Zishen Decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 41 55; KIM score≥ 15 points; The number of hot flashes and sweating≥ 3 times/day; Menopause time≥ 6 months; FSH>30mIU/ml,E2<30ng/L; Informed consent, voluntary testing. Exclusion Criteria: Unexplained vaginal bleeding; Sex hormone-related malignant tumors cannot be excluded; premature ovarian failure, or endometriosis, or hysterectomy, or bilateral adnexectomy; Combined with primary liver and kidney dysfunction, cardiovascular and cerebrovascular diseases, blood system diseases and other serious diseases that affect their survival; Exposure to sex hormone-related drugs within 3 months; Patients with mental abnormalities, or those with a history of alcohol or drug abuse; Those who have allergic reactions to the study drug; Those who are participating in other drug clinical researchers.

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the experimental group<br> | Drug: Qingxin Zishen Decoction<br>* Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.<br>|
| Active Comparator: the control group<br> | Drug: Femoston<br>* Fenmorphone (this product is a compound preparation, estradiol tablets contain estradiol 2mg; Estradiol dydrogesterone tablets contain estradiol 2 mg and dydrogesterone 10 mg). Usage: 1 time/day: 1 tablet orally every day, every 28 days as a course of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Kupperman Menopausal Index | The Modified Kupperman Menopausal Index is a scoring method to evaluate women's menopausal related symptoms, using the Kupperman index (KMI) score, including 13 menopausal related symptoms such as vasomotor symptoms, paresthesias, and insomnia ...Each symptom is divided into 0 to 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. | Baseline, at the 4th, 8th and 12th weeks of treatment | 
| Hot flashes and sweats on a five-level 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. Higher scores indicate more severe symptoms. | Baseline, at the 4th, 8th and 12th weeks of treatment | 
| sex hormone | Patients who met the inclusion criteria were collected 5 ml of cubital venous blood on an empty stomach before and after treatment, and serum estradiol (E2) and follicle-stimulating hormone (FSH) levels were detected by chemiluminescence method. | Baseline and 12th weeks of treatment | 
| Neuroendocrine indicators | The patients who met the inclusion criteria were fasted before and after treatment, and the levels of hypothalamic neuronal active peptide (kisspeptin), neurokinin B (NKB) and dynorphin (Dyn) were detected by enzyme-linked immunosorbent assay (ELISA). | Baseline and 12th weeks of treatment |