MenopauseNCT06143696
QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
A study testing Qingxin Zishen decoction and Femoston in people with Menopause, run by Yun Chen at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the differences of intestinal flora and saliva flora between menopausal women, and the changes after medication, to find the association between the two and menopausal syndrome. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Qingxin Zishen decoction and Femoston
- 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 Aug 2023to 30 Jun 2025
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Those who meet the diagnostic criteria for menopausal syndrome and the TCM heart and kidney syndrome differentiation criteria.
- Women between the ages of 45~55.
- The score of the modified Kupperman Menopausal Symptom Rating Scale ≥ 15 points.
- Hot flashes and sweating≥ 3 times/day.
- Menopause ≥ 6 months.
- FSH > 10U/L during menopausal transition, 40U/L > after menopause, and estradiol (E2) < (10~20) pg/mL.
- Informed consent, voluntary test. The process of obtaining informed consent should be in accordance with GCP regulations.
Who cannot join
- Other Chinese and Western drugs for the treatment of menopausal syndrome have been used after the onset of the disease.
- Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival.
- Contraindications to hormone therapy: known or suspected pregnancy; In perimenopausal women, menstrual disorders should be ruled out to exclude pregnancy-related problems such as intrauterine pregnancy, ectopic pregnancy, and trophoblastic disease. Unexplained vaginal bleeding: Causes of vaginal bleeding include neoplastic, inflammatory, iatrogenic, traumatic, and ovarian dysfunction, which should be carefully identified before perimenopausal menstrual disorders are treated with sex hormones. Known or suspected breast cancer. Known or suspected sex hormone-dependent malignancy. Active venous or arterial thromboembolic disease within the last 6 months. Severe hepatic and renal insufficiency.
- Those who are unable to give full informed consent due to intellectual or behavioral disabilities.
- Suspected or confirmed history of alcohol and drug abuse.
- Allergies, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of this medicine.
- Patients who are participating in clinical trials of other drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuxin Zhou
Nanjing, Jiangsu
Yuxin Zhou, +8615151835610, zyxemilia@163.com
About this study
Official title: Study on the (Heart) Brain-gut Axis Mechanism of Qingxin Zishen Decoction in Treating Hot Flashes in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
The goal of this clinical trial is to explore the differences of intestinal flora and saliva flora between menopausal women, and the changes after medication, to find the association between the two and menopausal syndrome. The main questions it aims to answer are:
- What are the differences in intestinal flora and saliva flora in menopausal women with hot flashes and sweating.
- Whether these differences change after using traditional Chinese medicine and the association between intestinal, salivary flora and menopausal syndrome. 60 patients will be screened according to the clinical experimental criteria. They will be randomly divided into trial group (30 cases) and control group (30 cases). The test group takes traditional Chinese medicine Qingxin Zishen decoction, and the control group takes oral Femoston, comparing the two groups with analysis of symptom improvement, intestinal flora and salivary flora with 16S rRNA sequencing technology.
- Conditions
- Menopause
- Being tested
- Qingxin Zishen decoction, Femoston
- Keywords
- menopause, 16S rRNA, saliva flora, intestinal flora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingxin Zishen decoctionDrug
Oral administration, 1 dose daily, twice a day
FemostonDrug
Oral administration, 1 pill each time, once a day
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | Qingxin Zishen decoction, oral administration, 1 dose a day, 2 times a day. For 28 days of medication, every 28 days. Observation time for 3 courses. Receives: Drug: Qingxin Zishen decoction |
| the control group | Active comparator | Femoston, oral, 1 each time, once a day. For 28 days of medication, every 28 days. Observation time for 3 courses. Receives: Drug: Femoston |
What is being measured
The primary outcome is the main question the study is designed to answer.
16s rRNA high-throughput sequencing of the gut flora
16s rRNA is a highly conserved gene segment in bacteria and archaea, together with some variability. Sequencing the 16S rRNA gene allowed us to identify different genera and species present in the microbial community and to assess their relative abundance.
Measured: Baseline (Before treatment) and 12th weeks of treatment
16s rRNA high-throughput sequencing of the saliva flora
16s rRNA is a highly conserved gene segment in bacteria and archaea, together with some variability. Sequencing the 16S rRNA gene allowed us to identify different genera and species present in the microbial community and to assess their relative abundance.
Measured: Baseline (Before treatment) and 12th weeks of treatment
Secondary outcomes (2)
Hot flashes and sweating on a five-point 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. The individual scores of the two groups before and after treatment at the end of the 4th, 8th and 12th weeks were compared.
Measured: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
Modified Kupperman rating scale
The Kupperman Index (KMI) score was used to include 13 menopausal related symptoms such as vasomotor symptoms, paresthesias, insomnia, etc., and each symptom was divided into 0-3 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. The individual scores and total scores of the two groups before and after treatment at the 4th, 8th and 12th weekends were compared
Measured: Baseline (Before treatment) at the 4th, 8th 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 posted22 Nov 2023
- Study start1 Aug 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
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 (estimated)
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
- NCT06143696
- Sponsor's protocol ID
- QXZS-Flora
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the (Heart) Brain-gut Axis Mechanism of Qingxin Zishen Decoction in Treating Hot Flashes in Menopausal Syndrome Based on 16S rRNA Sequencing Technology
- ClinicalTrials.gov ID
- NCT06143696
- Acronym / sponsor ID
- QXZS-Flora
- Conditions
- Menopause
- Keywords
- menopause, 16S rRNA, saliva flora, intestinal flora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yun ChenUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 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 explore the differences of intestinal flora and saliva flora between menopausal women, and the changes after medication, to find the association between the two and menopausal syndrome. The main questions it aims to answer are:
- What are the differences in intestinal flora and saliva flora in menopausal women with hot flashes and sweating.
- Whether these differences change after using traditional Chinese medicine and the association between intestinal, salivary flora and menopausal syndrome. 60 patients will be screened according to the clinical experimental criteria. They will be randomly divided into trial group (30 cases) and control group (30 cases). The test group takes traditional Chinese medicine Qingxin Zishen decoction, and the control group takes oral Femoston, comparing the two groups with analysis of symptom improvement, intestinal flora and salivary flora with 16S rRNA sequencing technology.
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 decoctionQingxin Zishen decoction, oral administration, 1 dose a day, 2 times a day. For 28 days of medication, every 28 days. Observation time for 3 courses. |
| the control group | Active comparator | Drug: FemostonFemoston, oral, 1 each time, once a day. For 28 days of medication, every 28 days. Observation time for 3 courses. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Those who meet the diagnostic criteria for menopausal syndrome and the TCM heart and kidney syndrome differentiation criteria.
- Women between the ages of 45~55.
- The score of the modified Kupperman Menopausal Symptom Rating Scale ≥ 15 points.
- Hot flashes and sweating≥ 3 times/day.
- Menopause ≥ 6 months.
Key exclusion criteria (7 listed)
- Other Chinese and Western drugs for the treatment of menopausal syndrome have been used after the onset of the disease.
- Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival.
- Contraindications to hormone therapy: known or suspected pregnancy; In perimenopausal women, menstrual disorders should be ruled out to exclude pregnancy-related problems such as intrauterine pregnancy, ectopic pregnancy, and trophoblastic disease. Unexplained vaginal bleeding: Causes of vaginal bleeding include neoplastic, inflammatory, iatrogenic, traumatic, and ovarian dysfunction, which should be carefully identified before perimenopausal menstrual disorders are treated with sex hormones. Known or suspected breast cancer. Known or suspected sex hormone-dependent malignancy. Active venous or arterial thromboembolic disease within the last 6 months. Severe hepatic and renal insufficiency.
- Those who are unable to give full informed consent due to intellectual or behavioral disabilities.
- Suspected or confirmed history of alcohol and drug abuse.
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 |
|---|---|---|
| Qingxin Zishen decoctionOral administration, 1 dose daily, twice a day | Drug | the experimental group |
| FemostonOral administration, 1 pill each time, once a day | Drug | the control group |
Primary outcome
16s rRNA high-throughput sequencing of the gut flora
Time frame: Baseline (Before treatment) and 12th weeks of treatment
16s rRNA is a highly conserved gene segment in bacteria and archaea, together with some variability. Sequencing the 16S rRNA gene allowed us to identify different genera and species present in the microbial community and to assess their relative abundance.
16s rRNA high-throughput sequencing of the saliva flora
Time frame: Baseline (Before treatment) and 12th weeks of treatment
16s rRNA is a highly conserved gene segment in bacteria and archaea, together with some variability. Sequencing the 16S rRNA gene allowed us to identify different genera and species present in the microbial community and to assess their relative abundance.
2 secondary outcomes
Hot flashes and sweating on a five-point scale.
Time frame: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
Modified Kupperman rating scale
Time frame: Baseline (Before treatment) at the 4th, 8th and 12th weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qingxin Zishen decoction and Femoston 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Chen (+8615151835610, fsyy00684@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16s rRNA high-throughput sequencing of the gut flora (time frame: Baseline (Before treatment) and 12th weeks of treatment). The study lists 2 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 22 Nov 2023.