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

NCT06132620 | Completed DMC

• 1 other identifier: QXZS-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

the experimental group

EXPERIMENTAL

Drug: Qingxin Zishen Decoction

the control group

ACTIVE COMPARATOR

Drug: Femoston

Interventions

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.

the control group

Qingxin Zishen Decoction DRUG

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

the experimental group

Eligibility Criteria

• Age: 41 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Chen: lead

Study Sites (1)

Yuxin Zhou

Nanjing, 南京, China

Location

MeSH Terms

Interventions

femoston

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 15, 2023
• Study Start: April 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)