Clinical trial
Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
Name
QXZS-1
Description
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.
Trial arms
Trial start
2017-04-01
Estimated PCD
2018-06-30
Trial end
2018-06-30
Status
Completed
Treatment
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.
Arms:
the control group
Qingxin Zishen Decoction
Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.
Arms:
the experimental group
Size
60
Primary endpoint
Modified Kupperman Menopausal Index
Baseline, at the 4th, 8th and 12th weeks of treatment
Hot flashes and sweats on a five-level scale
Baseline, at the 4th, 8th and 12th weeks of treatment
sex hormone
Baseline and 12th weeks of treatment
Neuroendocrine indicators
Baseline and 12th weeks of treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-11-15
1 organization
2 products
1 indication
Organization
Yun ChenProduct
FemostonIndication
MenopauseProduct
Qingxin Zishen Decoction