Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
NCT ID: NCT06132620
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-04-01
2018-06-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the experimental group
Qingxin Zishen Decoction
Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.
the control group
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.
Interventions
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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.
Qingxin Zishen Decoction
Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
41 Years
55 Years
FEMALE
No
Sponsors
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Yun Chen
OTHER
Responsible Party
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Yun Chen
Deputy Chief Physician
Locations
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Yuxin Zhou
Nanjing, 南京, China
Countries
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Other Identifiers
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QXZS-1
Identifier Type: -
Identifier Source: org_study_id
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