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

Sponsor
Yun Chen (Other)
Overall Status
Completed
CT.gov ID
NCT06132620
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
14.9
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: the experimental group

Drug: Qingxin Zishen Decoction
Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.
Active Comparator: the control group

Drug: Femoston
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.

Outcome Measures

Primary Outcome Measures

  1. Modified Kupperman Menopausal Index [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
41 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yuxin Zhou Nanjing 南京 China

Sponsors and Collaborators

  • Yun Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yun Chen, Deputy Chief Physician, Jiangsu Province Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT06132620
Other Study ID Numbers:
  • QXZS-1
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 15, 2023