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Kisspeptin-10

KP-10, Metastin (45-54), Kisspeptin-10 (human), KiSS-1

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Completed NA INTERVENTIONAL NCT06132620

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Interventions

Name: Femoston

Type: DRUG

Description: 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.

Name: Qingxin Zishen Decoction

Type: DRUG

Description: Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.

Primary Outcomes

Measure: Modified Kupperman Menopausal Index

TimeFrame: Baseline, at the 4th, 8th and 12th weeks of treatment

Description: 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.

Measure: Hot flashes and sweats on a five-level scale

TimeFrame: Baseline, at the 4th, 8th and 12th weeks of treatment

Description: 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.

Measure: sex hormone

TimeFrame: Baseline and 12th weeks of treatment

Description: 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.

Measure: Neuroendocrine indicators

TimeFrame: Baseline and 12th weeks of treatment

Description: 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).

Trial Information

NCT ID

NCT06132620

Status

Completed

Study Type

INTERVENTIONAL

Phases

Sponsor

Yun Chen

Last Updated

December 15, 2025