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Completed

NCT Number: NCT06132620

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

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.

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Key information

Conditions

Menopause

Age range

41 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yuxin Zhou

Nanjing, 南京, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femoston

Drug

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.

Qingxin Zishen Decoction

Drug

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

Primary outcomes

  1. Modified Kupperman Menopausal Index

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

    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.

  2. Hot flashes and sweats on a five-level scale

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

    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.

  3. sex hormone

    Time frame: Baseline and 12th weeks of treatment

    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.

  4. Neuroendocrine indicators

    Time frame: Baseline and 12th weeks of treatment

    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).

Sponsors and collaborators

Lead sponsor

Yun Chen

Other

Registry information

Acronym: QXZSKNDy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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