MenopauseQXZSKNDyNCT06132620
Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
A study testing Femoston and Qingxin Zishen Decoction in people with Menopause, run by Yun Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 55 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Femoston and Qingxin Zishen Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Femoston, Qingxin Zishen Decoction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemostonDrug
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 DecoctionDrug
Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | Not described Receives: Drug: Qingxin Zishen Decoction |
| the control group | Active comparator | Not described Receives: Drug: Femoston |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 12th weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Apr 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Chen, Jiangsu Province Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132620
- Sponsor's protocol ID
- QXZS-1
- Acronym
- QXZSKNDy
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
- ClinicalTrials.gov ID
- NCT06132620
- Acronym / sponsor ID
- QXZSKNDy / QXZS-1
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yun ChenUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Drug: Qingxin Zishen Decoction |
| the control group | Active comparator | Drug: Femoston |
Who may qualify
- Ages
- 41 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemostonFenmorphone (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. | Drug | the control group |
| Qingxin Zishen DecoctionQingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses. | Drug | the experimental group |
Primary outcome
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoston and Qingxin Zishen Decoction in people with Menopause, run by Yun Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Kupperman Menopausal Index (time frame: Baseline, at the 4th, 8th and 12th weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.